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Catalog Number PCDN1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Fistula (1862); Nausea (1970); Pain (1994); Perforation (2001); Seroma (2069); 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 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) 2019 during which the surgeon noted the procedure required extensive lysis of adhesions.The adhesions were so severe as to involve the appendix and part of the bowel, necessitating removal.It was reported that patient had hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.Other procedure was captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 8/17/2021.Additional b5 narrative: it was reported that the patient experienced recurrent incisional hernia, seroma, abscess, bowel perforation and fistula following surgery.
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Manufacturer Narrative
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Date sent to the fda: 10/06/2021.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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