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Lot Number 28396-03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Swelling/ Edema (4577)
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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) 2016 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted the peritoneum was highly adherent to the mesh that was previously implanted.He explanted the mesh.It was reported that the patient experienced chronic pain, swelling and adhesions.No additional information was provided.
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Search Alerts/Recalls
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