Product complaint # (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.The patient demographic info: age, gender, weight, bmi at the time of index procedure on what tissue was the suture used? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? what were current symptoms following the index surgical procedure? onset date? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? one patient instance ((b)(4)) reported ethilon product code 1669h and monocryl suture product code y427h.Were both sutures involved in this patient event? if yes, in what tissue was the ethilon suture and the monocryl suture used? please provide lot number for the monocryl suture.Other relevant patient history/concomitant medications.Lot # for the ethilon suture.Will product for the same product code/lot number be returned for evaluation? return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? monocryl device captured in mw 2210968-2020-01253.
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