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Model Number PVPS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, open draining wound, seroma, infection, cellulitis and unincorporated mesh.No additional information was provided.
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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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Search Alerts/Recalls
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