ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Abdominal Pain (1685); Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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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 surgical procedure on (b)(6) 2007 and two mesh products were implanted.It was reported that she experienced pain and erosion of her internal bodily tissue.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/07/2022.It was reported that the patient experienced discomfort, severe abdominal pain, recurrent urinary incontinence, urinary frequency, urinary tract infections.It was reported that the patient underwent removal surgery on (b)(6) 2019.
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Search Alerts/Recalls
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