Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); 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 a hernia repair procedure on (b)(6) 2013 and mesh was implanted.It was reported that the patient underwent a hernia repair procedure on (b)(6) 2014 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.Other implanted product is captured in a separate file.No additional information was provided.
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Manufacturer Narrative
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It was reported that the patient underwent mesh revision with new implant on 3/17/2014.It was reported that the patient experienced pain.
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Search Alerts/Recalls
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