(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. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WERE CULTURES PERFORMED? IF YES, RESULTS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. PRODUCT CODE AND LOT NUMBER. IF APPLICABLE, WILL PRODUCT BE RETURNED, RETURN DATE, TRACKING INFORMATION. WHAT IS THE PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT?S CURRENT STATUS?
D
Patient 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT SEWING IN SKIN LACERATION OF RIGHT HAND ON (B)(6) 2019 AND SUTURE WAS USED. DOCTORS USED SILK SUTURE TO SEW PATIENT WOUNDS AS PER NORMAL PROCEDURE. ON (B)(6) 2019, THE PATIENT SUFFERED FROM ERYTHEMA INFLAMMATION, AND PAIN AROUND THE WOUND. THE PATIENT WAS TREATED WITH STITCHES REMOVED AND RE-SUTURED, AND CEFALEXIN CAPSULES 0.25 G, 12 CAPSULES, 2 CAPSULES/TIME, 3 TIMES A DAY. FOR TWO DAYS LATER, THE SYMPTOMS OF ERYTHEMA, INFLAMMATION AND PAIN WERE IMPROVED. THEN THE PATIENT'S CONDITION CHANGED TO BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.