Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Hernia (2240); Injury (2348); Not Applicable (3189)
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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) 2011 and mesh was implanted.It was reported that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.Other procedure is captured on a separate file.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 11/6/2020.Additional b5 narrative: it was reported that following insertion the patient experienced recurrent hernia and adhesion.
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Search Alerts/Recalls
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