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Catalog Number 810081L |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Ulcer (2274)
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Event Date 01/12/2013 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2013 and mesh was implanted for incontinence.The patient experienced parietal ulceration, back pain, frequent sciatica, and very frequent urinary infections.An ultrasound on (b)(6) 2023 found the tape is located sagittally in projection of the lower third of the urethra located within the urethral wall compatible with parietal ulceration explaining the recurrent infections.No further information is available as the reporter contact was not disclosed.
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Search Alerts/Recalls
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