Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Inflammation (1932); Pain (1994); Seroma (2069)
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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) 2017 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted infection of the mesh and cutaneous fistula and seroma fluid requiring removal.It was reported that the patient experienced severe pain, inflammation and infection.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 08/26/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Date sent to the fda: 11/13/2021.
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Search Alerts/Recalls
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