Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Hernia (2240)
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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, multifocal repair procedure on (b)(6) 2008 and mesh x3 were implanted.It was reported that the patient underwent mesh revision on (b)(6) 2009 due to recurrent ventral incisional hernia, pain and adhesions.The patient had a previous mesh implanted on (b)(6) 2007 which is captured in a separate file.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 10/18/2022.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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