Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); No Code Available (3191)
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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 info 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) 1998 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 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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It was reported that the patient underwent a gynecological procedure and mesh was implanted concurrently with cystoscopy.
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Manufacturer Narrative
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Date sent to the fda: 01/05/2017.It was reported that following insertion the patient experienced recurrent urinary tract infection.It was reported that patient underwent removal of mesh on (b)(6) 1998 by dr.(b)(6).It was reported that patient underwent excision of mesh on (b)(6) 2011 by dr.(b)(6) due to recurrent stress urinary incontinence, and vaginal discharge.
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Search Alerts/Recalls
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