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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); 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.
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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) 2014 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020 during which the surgeon noted the mesh was displaced from the umbilical hernia site resulting in a number of recurrent hernias.The omentum was dissected free from each of the hernias.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: 7/4/2022.Additional information: a1, a2, b7.Additional b5 narrative: it was reported that following the procedure the patient experienced adhesion.
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Search Alerts/Recalls
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