(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.In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
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It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient underwent mesh revision on (b)(6) 2016 due to hernia recurrence, pain, fatigue and swelling.No additional information was provided.
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