Model Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); 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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Date sent to the fda: 08/23/2022.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 a hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced undisclosed adverse events.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/06/2022.Additional b5 narrative: it was reported that the patient underwent revision surgery on (b)(6) 2015.It was reported that the patient experienced severe abdominal pain, adhesions, hernia recurrence.
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Manufacturer Narrative
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Date sent to the fda: (b)(6)2022.Additional information: d1, d2, 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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