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Catalog Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Pain (1994); Hernia (2240); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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Date sent to the fda: 03/05/2021.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) 2011 and mesh was implanted.It was reported that the patient underwent a recurrent hernia during which the surgeon noted she lysed the adhesions in the anterior abdominal wall.It was reported the patient experienced pain, discomfort, and diarrhea.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 03/11/2021.Additional information: d4, h4.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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