It was reported that a patient underwent a sling procedure on (b)(6) 2018 and mesh was implanted.Following the implantation of the device, in a situation of disability.The patient experienced leg pain, cramping, stick feeling in the leg, inability to move, feeling like you want to get up and stretch, repeated urinary infections, back pain, burning sensation, sensation of knife in the vagina and inability to sit upright for long, to walk.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.
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