ETHICON INC. GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number PFRP01 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problems
Other (for use when an appropriate patient code cannot be identified) (2200); Discharge (2225); Surgical procedure (2357)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a posterior pelvic floor repair on 11/2010 and mesh was implanted.One year following the procedure, the patient experienced discharge and mesh exposure of posterior wall.It was reported that the patient underwent a mesh excision procedure.No additional information was provided at this time.
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Manufacturer Narrative
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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