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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); Nausea (1970); Pain (1994); Scar Tissue (2060); Hernia (2240); 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) 2016.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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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) 2015 and mesh was implanted.It was reported that the patient underwent partial removal surgery and recurrent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2018.It was reported that the patient experienced severe pain, nausea, inflammation, scarring, bulging, stress and anxiety.Other procedure is captured under separate file.No additional information was provided.
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Search Alerts/Recalls
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