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Model Number PHSL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Inflammation (1932); Pain (1994); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery, enterolysis, laparotomy with drainage of abdominal wall abscess and removal of umbilicus on (b)(6) 2019 during which the surgeon noted he encountered a large purulent cavity intimately associated with the mesh.The mesh was removed in its entirety and the fascia was debrided.It was reported that the patient experienced severe pain, infection, scarring, inflammation and stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/06/2021 additional information: d4, h4 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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