Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Fatigue (1849); Fistula (1862); Pain (1994); Numbness (2415)
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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 hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted adhesion of intra-abdominal mesh with erosion into the small bowel causing chronic draining of the fistulous tract.It was reported that the patient experienced severe pain, weakness and numbness.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 3/9/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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