(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 device history review has been inserted into the file.This review indicates that there was 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 procedure on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced abdominal pain, cellulitis, and infection of the abdominal wall following surgery.No additional information was provided.
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