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Model Number PCDJ1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Diarrhea (1811); Nausea (1970); Chills (2191)
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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.(b)(4) submitted for adverse event which occurred on (b)(6) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.
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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) 2007 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2010 during which the surgeon noted he performed an extensive lysis of adhesions, to take down the adhesions of omentum to the old mesh.There was one very densely adherent loop of bowel to the edge of the mesh at the hernia defect.It was reported that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.The other procedure is 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: 1/23/2024.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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