Model Number PHY1015V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
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.(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 a hernia repair surgery on (b)(6) 2011 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: 10/28/2022.
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Manufacturer Narrative
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Date sent to the fda: 11/03/2022.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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