Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Erosion (1750); Unspecified Infection (1930); Pain (1994); Swelling (2091); Hernia (2240)
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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.
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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) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2019.It was reported that the patient experienced mesh migration, infections, chronic pain and swelling abdomen.No additional information is provided.
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Manufacturer Narrative
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Date sent to the fda: (b)(6) 2020.Additional information: d4,h4.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 fda: 11/4/2020.Additional b5 narrative: it was reported that the patient experienced hernia recurrence, adhesions, erosion following the surgery.
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Search Alerts/Recalls
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