Catalog Number RML |
Device Problem
Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2001 and mesh was implanted.The patient underwent a second gynecological procedure on (b)(6) 2002 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was also reported that the patient has undergone multiple surgeries and revisionary procedures.Second procedure is captured under a separate file.No additional information was provided.
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Manufacturer Narrative
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Additional narrative: it was reported that the patient experienced small bowel obstruction and pelvic abscess.It was also reported that she underwent a mesh excision on (b)(6) 2003.
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Search Alerts/Recalls
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