Catalog Number PHY1520V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hernia (2240); Discomfort (2330); Injury (2348)
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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) 2013 and mesh was implanted.It was reported that the patient underwent previously hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.Other procedures are captured in a separate file.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: 09/24/2020.
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Manufacturer Narrative
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Date sent to fda: 10/30/2020.
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Manufacturer Narrative
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Date sent to the fda: 03/03/2021.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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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2021.Additional information: a1, a2, b7, d1,d2a, d4.Additional b5 narrative: it was reported that the patient experienced hernia recurrence, abdominal pain, discomfort following the procedure.It was reported that the patient underwent multiple revision surgeries.Date sent to the fda: (b)(6) /2021 corrected information: b7.
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Search Alerts/Recalls
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