Catalog Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Burning Sensation (2146)
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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 hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2015 during which the surgeon noted a large hernia sac almost 6x6 cm which appeared to have old mesh in it.It was dissected out.After excising the previous sutures, the retroperitoneal tissues were dissected out.It was reported that the patient experienced severe pain, burning and mrsa.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 3/29/2021.Additional information: a2, b7.
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Manufacturer Narrative
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Date sent to the fda: 05/25/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 4/6/2021.Corrected information: g1 - manufacturing site name and address.
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Search Alerts/Recalls
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