Catalog Number OPHY1010 |
Device Problem
Appropriate Term/Code Not Available (3191)
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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 surgery on (b)(6) 2015 and a mesh was implanted. it was reported that the patient experienced an undisclosed adverse event. it was reported that the patient had revision surgery on (b)(6) 2016.No additional information was provided.
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Manufacturer Narrative
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It was reported that following insertion the patient experienced pain.
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Manufacturer Narrative
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In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
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Search Alerts/Recalls
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