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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); 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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(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.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.
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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 that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted areas on the bowel that were adherent to the mesh with some areas of deserosalization.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2020.It was reported that the patient experienced severe pain, adhesions, bowel injury, bowel obstructions, and diarrhea.No additional information was provided.
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Search Alerts/Recalls
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