Model Number PCDB1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330)
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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) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013.It was reported that the patient experienced severe and chronic pain and discomfort, inflammation, abdominal wall reconstruction, scarring and mesh incarcerated within the hernia defect and stuck to preperitoneal fat and to the peritoneum.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/22/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 08/18/2022.Additional b5 narrative: it was reported that the patient experienced hernia recurrence and abscess formation following the procedure.Mwr-18082022-0001242364 submitted for adverse event which occurred on (b)(6) 2010.Mwr-18082022-0001242389 submitted for adverse event which occurred on (b)(6) 2013.
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Search Alerts/Recalls
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