(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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It was reported that the patient underwent an unknown procedure on unknown date and suture was used.During the procedure, before opening the product, the nurse held the packet up to the light to inspect it and saw pinholes in the packaging material.Another like suture was used to complete the procedure.There were no adverse consequences for the patient reported.Additional information has been requested.
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