Model Number PCDH1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Burning Sensation (2146); Discomfort (2330)
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Event Type
Injury
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Manufacturer Narrative
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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.(b)(4) submitted for adverse event which occurred on (b)(6) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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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) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2012.It was reported that the patient underwent revision surgery on (b)(6) 2018.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, extensive lysis of adhesions and burning sensation.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 11/11/2021.Additional information: a1, a2, b7 date sent to the fda: 11/11/2021.Corrected b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.
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Manufacturer Narrative
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Date sent to the fda: 12/01/2021.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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