ETHICON INC. GYNECARE TVT W/PRLNE BLUE MESH 1 EACH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number 810041B |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Urinary Tract Infection (2120); Urinary Frequency (2275); Abdominal Distention (2601)
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Event Date 09/08/2008 |
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 an unknown date and mesh was implanted.The patient reported experiencing bloating, sore back, not feeling 100%, bleeding during intercourse, blood loss on toilet and urinary tract infections every 4 months or so (recent changes).The patient's stress urinary incontinence is controlled and overactive bladder is managed via botox.No further information is available as reporter details have not been disclosed (confidential).
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Search Alerts/Recalls
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