FOI release

Freedom of Information request on the adverse reactions reported for neuromuscular simulator devices (FOI 22/436)

Published 31 May 2022

© Crown copyright 2022

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-21-february-2022/freedom-of-information-request-on-the-adverse-reactions-reported-for-neuromuscular-simulator-devices-foi-22436

FOI 22/436

21st February 2022

Dear

Thank you for your information request, dated 03/02/2022 and further clarification of the request dated 10/02/2022, where you asked for:

  1. ‘serious adverse events or adverse events for the period from the 01/01/2016 to the 03/02/2022’ in relation to dropped foot electrical and neuromuscular simulator devices manufactured by Odstock Medical.

  2. any serious adverse events or adverse events reported for other manufacturers of external dropped foot electrical stimulation devices or other external neuromuscular electrical stimulation devices.

MHRA adverse incident database was searched for any adverse events reported by any source between January 2016 and February 2022 using the key words ‘dropped foot electrical stimulation’ and ‘neuromuscular electrical stimulation’ for external application.

The search did not provide any results and no reports were identified.

These results are accurate at the time we extract them from our database.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

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

Back to top