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Model Number PVPM |
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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Event Description
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It was reported by an attorney that the patient underwent an incisional hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2021.It was reported that the patient experienced other undisclosed adverse events.No additional information was provided.
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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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Search Alerts/Recalls
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