Freedom of Information request (FOI 22/776)
Published 17 January 2024
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8th August 2022
FOI 22/776
Dear ,
Thank you for your enquiry dated 22 June 2022 regarding the use of extracorporeal shock wave lithotripsy for treating kidney stones.
Regarding your request for all reported adverse reactions and fatalities related to the procedure within the last 15 years, I can confirm that there have been no reports of patient harm involving external lithotripsy since 2013.
Unfortunately, we only hold records dating back to 2013 so are unable to provide information for the complete range requested.
Please be assured that patient safety is of paramount importance to the MHRA and we keep the safety of medicines and medical devices under close review and will communicate to patients and healthcare professionals should a new safety concern be identified.
We would encourage any individuals who suspect they may have experienced an adverse reaction to a medicine or medical device to report this to the Yellow Card Scheme: https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/
I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
If you have a query about the information provided, please reply to this email.
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If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000