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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2021.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2021.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent explant surgery on (b)(6) 2021 during which the surgeon noted the wound was chronically inflamed and adherent to the previously placed mesh.The doctor confirmed that he suffered from chronic draining sinus tract on the medial end of this right inguinal wound, running from his skin to the subcutaneous tissue.He encountered a pocket of purulent material before debriding the sinus tract, allowing him to then remove the prior mesh in a piecemeal fashion.It was reported that the patient underwent wound irrigation on (b)(6) 2021.It was reported that the patient underwent removal surgery on (b)(6) 2021 during which the surgeon noted a pocket of pus before encountering the mesh deep in the medial aspect of the wound.He removed the mesh, as well as the necrotic tissue, before irrigating and suctioning the wound.It was reported that the patient experienced an unknown adverse event.No additional information was provided.
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