(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.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2018.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery with an incision and debridement procedure of the left groin abscess on (b)(6) 2017.It was reported that the patient underwent removal surgery, exploration of left groin wound, and debridement of foreign body, muscle, and fascia of the left groin on (b)(6) 2018.It was reported that the patient experienced infection, abscess, draining sinus tract, chronically infected wound and tissue, irrigation and debridement, infected mesh, severe pain, and discomfort.No additional information was provided.
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