Date sent to the fda: 09/19/2022 (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) 2010.(b)(4) submitted for adverse event which occurred on (b)(6) 2022.
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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 hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2022.It was reported that the patient experienced severe pain, bowel scarring, adhesions, nausea, inflammation, bulging, scarring, stress and anxiety.No additional information was provided.Other procedures are captured in separate files.
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