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Patient 1
(B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MGK215 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. -IN THE CLINIC SUTURE MATERIAL HAD BEEN USED BY THE DEPARTMENT OF TRAUMATOLOGY AND ORTHOPEDICS 2.5-3 MONTHS BEFORE THE APPEARANCE OF ADVERSE EVENTS IN THE DEPARTMENT ON THE PATIENTS WITH RECONSTRUCTIONS ON ALL SUTURED LAYERS IN THE SURGICAL WOUND. THEN THE PATIENTS HAD BEEN DISCHARGED TO HOME. AFTER 2.5-3 MONTHS THEY WERE HOSPITALIZED AGAIN IN THE EMERGENCY SURGICAL DEPARTMENT. ALL AVAILABLE INFORMATION FROM DEPARTMENT OF TRAUMATOLOGY AND ORTHOPEDICS ABOUT PATIENT DATA IS BELOW. PATIENT DATA OF THIS COMPLAINT ((B)(4)): MALE, (B)(6) YEARS OLD, WEIGHT (B)(6), RE-HOSPITALIZATION FOR REMOVAL OF FISTULAS. FISTULAS FORMED ON BOTH FEET AFTER MYOTENDOPLASTY IN 3 MONTHS. FISTULAS WERE EXCISED, THE REMAINS OF THE THREADS WERE REMOVED. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: DATE OF THE INITIAL SURGERY. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? IT WAS REPORTED THE ?SURGERY WAS ON THE FOOT AND LIGATURE FISTULA FORMED IN SCAR AREA ON LEFT LEG?. PLEASE CLARIFY: ON WHAT TISSUE AND LOCATION WAS THE SUTURE PLACED? IN WHAT TISSUE/STRUCTURE WAS THE FISTULA LOCATED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT WERE THE CURRENT SYMPTOMS FOLLOWING THE INITIAL PROCEDURE? WHAT DATE DID THE PATIENT PRESENT WITH SYMPTOMS? IF SECOND OPERATION WAS PERFORMED, WHAT WAS THE APPEARANCE OF THE SUTURE DURING THE REOPERATION? IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING OR AFTER SUTURE PLACEMENT OR DURING ANY RE-OPERATIONS? DOES THE SURGEON BELIEVE THERE WAS ANY SUTURE DEFICIENCY THAT LEAD TO THE POST-OP COMPLICATIONS? WHAT IS PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT PATIENT?S CURRENT STATUS? NOTE: EVENTS REPORTED VIA MW # 2210968-2020-01779, 2210968-2020-01780.