Model Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 10/04/2022.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) 2008 and two mesh products were implanted.It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted multiple adhesions and a large recurrent hernia.The mesh was wadded up with the rectosigmoid remnant and metal tacks were exposed.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 01/25/2023.
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Manufacturer Narrative
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Date sent to the fda: 02/07/2023.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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