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); Nausea (1970); Pain (1994); Scar Tissue (2060); Chills (2191)
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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) 2019 during which the surgeon noted dense adhesions requiring two hours of dissection.Abdomen was described as essentially frozen.The surgeon had to give up at some point for fear of damaging the bowel and other organs.The surgery was complicated by the degree of adhesions and severe scar tissue.Pieces of mesh were removed bit by bit.Portions of mesh remain as it was not possible to remove all mesh or lysis all adhesions.It was reported that the patient experienced severe pain, nausea, chills and inflammation.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 5/12/2022.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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