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) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2011.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.
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It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2010.It was reported that the patient underwent partial removal surgery on (b)(6) 2011.It was reported that the patient underwent partial mesh removal surgery on (b)(6) 2011.It was reported that the patient underwent removal surgery on (b)(6) 2013.It was reported that the patient experienced severe pain, adhesions, mesh dissection, debridement due to adhesions, non-healing wound, infection, stress and anxiety.No additional information was provided.
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