SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. THE SURGEON USES THE PRODUCT ON THE VAGINAL CUFF. HE HAS HAD THREE SURGICAL SITE INFECTIONS SINCE CONVERTING TO THE PRODUCT FROM FLOSEAL IN OCTOBER. HE THINKS THE PRODUCT MIGHT BE GIVING HIS PATIENT¿S SSI¿S. NO SURGICAL DELAY WAS REPORT. ADDITIONAL INFORMATION WAS REQUESTED

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ¿ WHAT IS THE NAME OF EACH PROCEDURE? ALL 3 REPORTS WERE FROM TOTAL HYSTERECTOMIES ¿ WHAT WAS THE DATE OF EACH PROCEDURE? PATIENT (B)(6): (B)(6) 2025; PATIENT (B)(6): (B)(6) 2025; PATIENT (B)(6): (B)(6) 2025 ¿ ON WHAT DATE DID EACH INFECTION OCCUR? PATIENT (B)(6): (B)(6) 2025; PATIENT (B)(6): (B)(6) 2025; PATIENT (B)(6): (B)(6) 2025 ¿ HOW MUCH SURGIFLO WAS USED DURING EACH PROCEDURE? ONE UNIT OF 2994 WAS USED PER PATIENT/CASE. ¿ WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED? SURGIFLO WAS NOT REMOVED AFTER HEMOSTASIS ON ANY OF THE 3 PATIENTS. WHAT WAS THE INDICATION FOR THE USE OF SURGIFLO? HEMOSTASIS AFTER THE VAGINAL CUFF WAS CLOSED. WHAT WAS THE INDICATION FOR SURGERY? REMOVAL OF THE UTERUS AND CERVIX FOR ALL 3 PATIENTS. WHAT WAS THE MEDICAL HISTORY OF EACH PATIENT? PATIENT (B)(6): UTERINE FIBROIDS; PATIENT (B)(6): ENDOMETRIOSIS; PATIENT (B)(6): ADENOMYOSIS. WHAT WAS THE TREATMENT FOR EACH SURGICAL SITE INFECTION? OPEN AND DRAIN THE WOUND, REMOVE SUTURES, IRRIGATION AND DEBRIDEMENT, ANTIBIOTICS FOR ALL 3 PATIENTS. WHAT ARE THE LOT NUMBERS? I WAS NOT GIVEN THE LOT NUMBERS AS IT WAS REPORTED AFTER THE SURGICAL DATES. CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? I ASKED FOR THIS INFORMATION, AND THE SURGEON WOULD NOT PROVIDE IT. WHAT IS THE SURGEON¿S OPINION REGARDING THE RELATIONSHIP BETWEEN THE PRODUCT AND THE SYMPTOMS? THE SURGEON BELIEVES THE ONLY PROTOCOL THAT WAS CHANGED WAS MOVING FROM FLOSEAL TO SURGIFLO DURING THE 3 SSIS. WHAT IS THE CURRENT CONDITION OF EACH PATIENT? ALL 3 PATIENTS HAVE RECOVERED FROM THEIR SSIS AND ARE HEALTHY IN THAT REGARD. 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. 1. WAS THERE ANY SURGICAL CONTAMINATION OR INJURY DURING THE INITIAL OPERATION? 2. WERE CULTURES PERFORMED? IF YES, WHAT WERE THE RESULTS? 3. PLEASE DESCRIBE THE PATIENT MANIFESTATIONS OF THE REPORTED INFECTION (LOCATION, SEVERITY, APPEARANCE). 4. WERE THERE ANY PRE-EXISTING SIGNS/SYMPTOMS OF ACTIVE INFECTION PRIOR TO THIS SURGICAL PROCEDURE? 5. HOW MUCH AND WHAT TYPE OF DRAINAGE IS PRESENT IN THIS WOUND? (IF APPLICABLE) 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.