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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); 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) 2010.And mesh was implanted.It was reported that the patient underwent revision surgery (b)(6) 2016.It was reported that the patient experienced severe pain, nausea, inflammation, dense adhesions, loss of appetite, stress and anxiety.No additional information was provided.
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Manufacturer Narrative
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Date sent to the fda: 10/25/2023.Additional b5 narrative: it was reported that the patient experienced recurrent hernia following surgery.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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