It was reported that a patient underwent an anterior colporrhaphy and posterior colporrhaphy on (b)(6) 2007 and mesh was implanted.The patient experienced urinary infections, incontinence, unbearable pain and discomfort.No further information is available as the reporter contact details were not disclosed.
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via: 2210968-2024-00625.
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