Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930)
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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 recurrent ventral incisional hernia repair procedure on (b)(6) 2013 and mesh was implanted.It was reported the patient underwent mesh removal on (b)(6) 2013 due to adhesions and infection.The patient had a previous mesh implanted on (b)(6) 2012 which is captured in a separate file.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: 08/14/2022.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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