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Model Number PVPM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Inflammation (1932); Nausea (1970); 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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(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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Event Description
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2018, and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted the previously implanted mesh had herniated through the recurrent fascial defect.It was reported that the patient experienced severe pain, nausea, inflammation, loss of appetite and discomfort.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 2/18/2021.H6: appropriate term / code not available (e2402) utilized to capture infections (e19).Additional b5 narrative: it was reported that the patient experienced infection and hematoma following surgery.
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Search Alerts/Recalls
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