Catalog Number OPHY1215 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Injury (2348)
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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) 2016 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
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Manufacturer Narrative
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Date sent to fda: 1/16/2019 additional narrative: it was reported that following insertion the patient abdominal pain, chronic pain, and no appetite.It was reported that the patient underwent excision of mesh and lysis of adhesion on (b)(6) 2017 due to adhesion and infection.No additional information was provided.
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Search Alerts/Recalls
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