ETHICON INC. PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Migration (4003)
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Patient Problems
Abdominal Pain (1685); Erosion (1750); Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 12/3/2020.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) 2006 and mesh x2 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: 09/13/2021.H6: appropriate term / code not available (e2402) utilized to capture infections (e19).Additional b5 narrative: it was reported that the patient experienced vaginal pain, vaginal burning, vaginal bleeding, abdominal pain, urinary infections, mesh erosion, scarring, urinary incontinence and constipation following surgery.It was reported that the patient underwent mesh removal on (b)(6) 2019.
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Search Alerts/Recalls
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