Model Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240)
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Event Type
Injury
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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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Event Description
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It was reported by an attorney that the patient underwent a ventral hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012.It was reported that the patient experienced pain, nausea, diarrhea, chills, inflammation and other undisclosed adverse events.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/26/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 10/07/2022.Additional b5 narrative: it was reported that following the procedure the patient experienced adhesion, abdominal pain and hernia recurrence.
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Search Alerts/Recalls
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