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Model Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Inflammation (1932); Pain (1994); Perforation (2001)
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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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2016.It was reported that the patient experienced severe pain and chronic pain/discomfort, inflammation, adhesions, adhesions to the small intestine, bowel perforation, bowel resection and open draining wound.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/07/2021.Additional information: a2, b7, d3.Additional b5 narrative: it was reported that the patient experienced mesh erosion following surgery.Date sent to the fda: 10/06/2021.Corrected information: a1, a3.
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Manufacturer Narrative
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Date sent to the fda: 11/19/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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