Catalog Number PHY2025V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422); 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 the patient experienced an undisclosed adverse event.No additional information was provided.
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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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Manufacturer Narrative
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Date sent to the fda: 3/28/2022.Additional b5 narrative: it was reported that the patient underwent mesh excision on (b)(6)2020 due to recurrent ventral hernia, adhesions, discomfort and obstruction.
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Manufacturer Narrative
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Date sent to the fda: 3/31/2022.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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