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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); Hernia (2240); Decreased Appetite (4569); 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 bilateral hernia repair surgery on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted there was a lot of adhesions at this area and he began doing careful dissection of the omentum off of the anterior abdominal wall, which revealed that the mesh had kind of ripped free from the previous umbilical hernia repair and moved over towards the left side and all the adhesions were actually up to the mesh more so than to the new hernia defect.It was reported that the patient experienced severe pain, nausea, diarrhea, drainage, inflammation and loss of appetite.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 02/07/2022.
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Search Alerts/Recalls
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