(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the operating surgeon observe any suture deficiency or anomaly before, during or after its use in the patient? did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? what is the number of devices where the needle pulled off from the suture? did this occur in multiple patient procedures? if so: what is the number of patient procedures were any of these events previously reported to ethicon? what was the name of the procedure? what is the date of the procedure? is the product or representative sample (product from the same lot number) available for evaluation? can you identify the product code(s) and lot number(s) of the product that was used? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
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