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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); 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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Appropriate term/code not available (e2402) utilized to capture digestive problems.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 hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2011 during which the surgeon noted intense inflammation in the tissue embedded in the mesh.It was reported that the patient experienced digestive problems and severe pain.It was reported had underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted which was captured in a separate file.No additional information was provided.
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Search Alerts/Recalls
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