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); Pain (1994); Obstruction/Occlusion (2422)
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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) 2008 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2008 during which the surgeon noted there was adherence of the small bowel towards the mesh and a pool of bile had formed.The mesh was removed and a gram stain test showed the presence of white cells and gram negative rods, indicating infection.It was reported that the patient experienced excruciating pain and partial bowel obstruction, lyse of adhesions and continual injections for pain management.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/31/2022.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: 9/12/2022.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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