Catalog Number PHY1520R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hernia (2240); 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 a ventral midline incisional hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2018.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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(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: 12/13/2022.Additional b5 narrative: it was reported that following the procedure, patient experienced abdominal pain and hernia recurrence.
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Search Alerts/Recalls
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