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(All manufacturers) foam heads of oral swabs may detach from the stick during use, which may present a choking hazard for patients. (MDA/2012/020)
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(Poly Implant Prothese (PIP) no guarantee that silicone gel breast implants manufactured before 2001 contain approved filler. (MDA/2012/011)
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(Covidien) reports of serious injuries after use of Stapler Duet TRS™ loading units in the thoracic cavity.(MDA/2012/005)
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(GE Healthcare) accidental incorrect setting of the ACGO switch results in no fresh gas flow to the patient.(MDA/2011/108)
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(All manufacturers) some pre-filled glass syringes are incompatible with some needle-free connectors; and when adaptor stays attached after use there is a possible risk of infection and or air embolus to patients. (MDA/2011/…
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(Hospira Inc) audible alarm on listed Plum A+ infusion pumps may fail, which could cause a delay or interruption to treatment. (MDA/2011/066)
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(Medtronic) use of Sprint Fidelis ICD lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (MDA/2011/051)
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(Covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (MDA/2011/026)
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(All) uncertain evidence that women with breast implants may have a very small but increased risk of anaplastic large cell lymphoma (ALCL) of the breast - none reported in the UK. (MDA/2011/017)
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(Poly Implant Prothese (PIP)) advice for implanting surgeons to identify women with PIP implants and advise them that further testing will be carried out. (MDA/2010/078)
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(All brands) risk of back-tracking when an IV line has multiple access ports, which can lead to under-infusion or bolus delivery of IV drugs. (MDA/2010/073)
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(Merz Pharmaceuticals GmbH) manufacturer has received reports of adverse reactions to the filler. (MDA/2010/064)
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(All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002. (MDA/2010/054)
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(Edwards Lifesciences Ltd, supplied by Baxter Healthcare) reports that the wheels break if not used properly, which could cause the machine to fall over to cause injury and interrupt therapy. (MDA/2010/039)
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(All) harm of inadequate patient ventilation and oxygenation could have been avoided if an alternative means of ventilation had been used earlier. (MDA/2010/036)
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(Poly Implant Prothese (PIP)) French medical device regulatory authority (AFSSAPS) found the composition of silicone gel for most breast implants have been different to the one approved since 2001 (MDA/2010/025)
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(All manufacturers) potential for the red and blue Hansen type dialysis fluid line connectors to be incorrectly configured (interchanged) which results in significantly less efficient dialysis. (MDA/2010/020)
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(intraocular lens (IOL) - hydrophilic acrylic) opacification of intraocular lens (IOLs) may occur following intracameral use of alteplase. (MDA/2010/008)
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(All makes and models) MHRA receives reports of uterine wall injury, wall perforation or the creation of a false passage after use of endometrial ablation devices. (MDA/2010/006).
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(All types of bed mattresses) body or other fluids can pass through and contaminate inner core of damaged mattresses or covers and cause cross-infection if used. (MDA/2010/002)
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(All manufacturers) Potential onward transmission of abnormal prion protein when ultrasound transducer probes with internal lumen during transrectal prostate biopsies on men at risk of vCJD. (MDA/2009/080)
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(Edwards Lifesciences Ltd) the manufacturer has updated their corrective actions for software problems with haemofiltration machines. (MDA/2009/076)
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(All makes and models) premature failure of bioprosthetic heart valves if they are not properly washed or rinsed before implantation. (MDA/2009/032)
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(Medtronic) Risk of delays in the resumption of drug infusion and in logging of motor stall events after MRI scans. (MDA/2008/087)
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(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)
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(Medtronic) error in the programmer software (revision NNB_01) which may lead to false warnings of a low battery status. (MDA/2008/065)
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(All manufacturers) inflammatory or granulomatous mass formation at the catheter tip causes a risk of temporary or permanent neurological impairment. (MDA/2008/038)
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(Medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the UK including an investigation into a fatality. (MDA/2007/078)
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(All ) concerns that some insecure adaptor systems are being used to connect temporary pacing leads to external pacemakers. (MDA/2007/042)
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(All) MHRA continues to receive adverse incident reports of patient hoists and slings used in hospitals and the community that have resulted in serious patient injury or fatalities. (MDA/2007/031)
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(Baxter Healthcare Ltd.) potential to be a contributing factor to changes in thyroid such as hypothyroidism. (MDA/2006/022)
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(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)
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(St Jude Medical) potential reduction in number of shocks (skipped charge) delivered per therapy episode and inappropriate rate responsive pacing for up to 90 minutes. (MDA/2005/045)
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(Lipomatrix Inc) conclusions of research after device was recalled for risks of break down of filler and update of HN2000(05). (MDA/2004/047)
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(All) malfunction and failure during use. (MDA/2003/037)
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(Medtronic) diamorphine solution is incompatible with the implantable drug pump. (MDA/2003/035)
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(Trophy (now owned by Carestream Health)) Risk of injury from falling unit after failure of the wall mount bracket. (MDA/2013/053)