Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); 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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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery.It was reported that the patient experienced severe pain, nausea, inflammation, loss of appetite, weakness, stress and anxiety.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 2/27/2022.H6: appropriate term / code not available (e2402) utilized to capture meshoma.Additional b5 narrative: it was reported that the patient underwent removal of mesh surgery on (b)(6) 2013 due to meshoma.
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Manufacturer Narrative
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Date sent to the fda: 3/9/2022.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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