Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); 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.Mwr-21032022-0001152040 submitted for adverse event which occurred on an unk date.Mwr-21032022-0001152039 submitted for adverse event which occurred on (b)(6) 2020.
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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) 2013 and mesh was implanted.It was reported that the patient underwent revision surgery on an unk date.It was reported that the patient underwent removal surgery on (b)(6) 2020.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: 7/26/2022 additional b5 narrative: it was reported that following the procedure, patient experienced bleeding, adhesions and recurrent hernia.
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Manufacturer Narrative
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Date sent to the fda: 7/29/2022.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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