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Model Number PCDG1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Diarrhea (1811); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)
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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.
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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) 2014 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted ¿it was extremely difficult peeling the mesh off the omentum and this took a significant amount of time as the mesh appeared was densely adherent.There was some fibrinous exudate on the mesh suggesting that this may have been an infection causing the mesh not to incorporate and to pull away from the abdominal wall.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 7/29/2024.It was reported that the patient experienced vomiting.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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Manufacturer Narrative
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Date sent to the fda: 8/14/2024.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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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