Catalog Number PMII |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Erosion (1750); Pain (1994); Injury (2348)
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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) 2002 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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In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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Manufacturer Narrative
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Date sent to the fda: 12/8/2020.Additional information: d3, e1, g1, g4.Additional b5 narrative: it was reported that she experienced pain and erosion of her internal bodily tissues.It was reported that the patient has undergone multiple surgeries and revisionary procedures.
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Search Alerts/Recalls
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