Model Number PCDG1 |
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)
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Event Type
Injury
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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) 2019 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted there were extensive adhesions in the abdomen to the anterior abdominal wall and mesh and those were carefully lysed.During the lysis of adhesions, a small area of oozing on the surface of the left lobe of the liver occurred which was inherent and unavoidable due to the nature of the adhesions.It was reported that the patient experienced severe pain, nausea and inflammation.No additional information was provided.
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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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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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