SUTURE UNKNOWN

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: WAS THE SUTURE USED MANUFACTURED BY ETHICON? WHAT TYPE OF SUTURE WAS USED? VICRYL? PRODUCT CODE AND LOT NUMBER? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. WERE ANY CONCOMITANT PROCEDURES PERFORMED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? FOR THE ORIGINAL INTENDED CLOSURE, HOW WERE ALL LAYERS CLOSED? HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? HOW WAS THE SUTURE ORIGINALLY TIED (MULTIPLE KNOTS, SQUARE KNOT, ETC.)? PLEASE DESCRIBE ANY MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THIS SUTURE EVENT INCLUDING DATES AND RESULTS. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? WHAT WERE THE CULTURE AND SENSITIVITY RESULTS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS?

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL DELIVERY VIA VAGINAL SIDE INCISION ON (B)(6) 2025 AND SUTURE WAS USED LAYER BY LAYER. RETURN TO THE WARD FOR REST WITHIN 2 HOURS AFTER DELIVERY WITHOUT SPECIAL ARRANGEMENTS. DISCHARGED ON THE 4TH DAY AFTER SURGERY. ON THE 9TH DAY AFTER SURGERY, THE PARTURIENT CALLED THE OBSTETRICS DEPARTMENT TO REPORT UNBEARABLE PAIN IN THE PERINEAL WOUND. THE ATTENDING DOCTOR INSTRUCTED HER TO RETURN TO THE HOSPITAL FOR A FOLLOW-UP EXAMINATION. UPON ARRIVAL, IT WAS FOUND THAT THE WOUND HAD A STRANGE ODOR, TORN SUTURES, POOR SUCTION AND POOR WOUND HEALING. SECRETIONS WERE COLLECTED AND SENT FOR EXAMINATION. THE WOUND WAS TREATED WITH DEBRIDEMENT AND POTASSIUM PERMANGANATE SITZ BATH WAS PRESCRIBED. THE PATIENT RETURNED TO THE HOSPITAL FOR A FOLLOW-UP EXAMINATION ONE WEEK LATER. AFTER COMMUNICATION AND EXPLANATION, THE FAMILY AND THE MOTHER EXPRESSED UNDERSTANDING OF THE CONDITION AND HAD NO OBJECTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED THAT OUR DEVICE WAS NOT USED DURING THE PROCEDURE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.