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Catalog Number 810081 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Incontinence (1928); Pain (1994); Depression (2361)
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Event Date 01/01/2008 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2005 and mesh was implanted.The pelvis mesh twisted and adhered to the public bone in multiple places causing immobility and chronic pain.The patient further experienced disability, treatments and medications, painful sexual intercourse, side effects from opiate pain relief, social isolation and depression.The mesh was removed on (b)(6) 2023.Stress urinary incontinence was noted after mesh removal.No further information is available as reporter details have not been disclosed (confidential).
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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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Search Alerts/Recalls
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