Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); Obstruction/Occlusion (2422)
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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) 2010 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 and chronic pain/discomfort, inflammation and adhesions.No additional information was provided.
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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.
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Manufacturer Narrative
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Date sent to the fda: 08/29/2022 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 the fda: 8/17/2022.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia, obstruction and scarring following surgery.
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Search Alerts/Recalls
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