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Model Number PCDN1 |
Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Hernia (2240); Weight Changes (2607); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 revision surgery and recurrent hernia repair surgery on (b)(6) 2011 and mesh was implanted during which the surgeon noted it was found to have adhered and failed.It was reported that the patient underwent revision surgery on (b)(6) 2014 during which the surgeon noted it was found to have failed and migrated into the hernia sac.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The patient had a previous mesh implanted on (b)(6) 2009 which is captured in separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 1/27/2022.
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Manufacturer Narrative
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Date sent to the fda: 2/23/2022.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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