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Model Number PVPS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Fibrosis (3167); Decreased Appetite (4569)
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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 hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted an inflammatory response.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 09/30/2022.Additional information: a2, b7, d4.Additional b5 narrative: it was reported that the patient experienced fibrosis.Mwr-30092022-0001269493 submitted for adverse event which occurred on (b)(6) 2013.Mwr-30092022-0001269507 submitted for adverse event which occurred on (b)(6) 2012.
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Search Alerts/Recalls
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