Device Problems
Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Injury (2348); Not Applicable (3189)
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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) 2000 and mesh was implanted.It was reported that she experienced undisclosed injuries.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 total abdominal hysterectomy and bilateral salpingo-oophorectomy.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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