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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)
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Event Type
Injury
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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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Event Description
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It was reported by an attorney that the patient underwent an incisional hernia repair surgery on (b)(6) 2020 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020.It was reported that the patient experienced pain, nausea and inflammation.No additional information was provided.
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Search Alerts/Recalls
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