BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-4 PMP

    MDR report key: 20202394 · Received September 12, 2024

    Report

    Report Number
    2210968-2024-09608
    Event Type
    Injury
    Date Received
    September 12, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031240889
    PMA / PMN Number
    K192144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. UNK. DATE OF INDEX SURGICAL PROCEDURE? ON (B)(6) 2024. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? UNK. ON WHAT TISSUE WAS THE SUTURE USED? DERMIS. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? NO SPECIAL CONDITION WAS REPORTED. DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? NO. WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? YES. WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? YES. WHEN DID THE BLEEDING BEGIN? HOW MANY HOURS/DAYS AFTER SURGERY? UNK. WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING? THE EDGE OF WOUND. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? ANTICOAGULANT (WARFARIN POTASSIUM). WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? THEY BELIEVE THAT THE BLEEDING MAY HAVE BEEN CAUSED BY THE ANTICOAGULANT MEDICATION SHE WAS TAKING. WHAT IS THE PATIENT'S CURRENT STATUS? STABLE AND DISCHARGED. LOT NUMBER? UNK.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT "...BLEEDING WAS FOUND FROM WOUNDCHEK AFTER THE SURGERY..." HOW MUCH BLOOD DID THE PATIENT LOST? CONFIRM THE QTY IN CC? THE AMOUNT IS UNK, BUT THE DEGREE OF BLEEDING WAS SLIGHT. WAS ANY BLOOD TRANSFUSION NECESSARY? NO. IT WAS REPORTED THAT "...COMPRESSION HEMOSTASIS WAS PERFORMED, AND NYLON WAS USED TO REINFORCE..." PLEASE PROVIDE MORE DETAILS. ASTRICTION WAS PERFORMED TO THE BLEEDING SITE, AND TO REINFORCE THE CLOSURE OF THE WOUND, INTERRUPTED NYLON SUTURE WAS ADDED. 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. PLEASE PROVIDE THE PATIENT'S WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE OF INDEX SURGICAL PROCEDURE? THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? WAS THE FIXATION LOOP SECURED TO TISSUE AT THE INITIATION OF SUTURE USE DURING THE INDEX PROCEDURE? WAS AT LEAST ONE REVERSE STITCH PERFORMED PRIOR TO CLOSURE? WHEN DID THE BLEEDING BEGIN? HOW MANY HOURS/DAYS AFTER SURGERY? WHAT WAS THE SOURCE AND TRIGGERING EVENT OF BLEEDING? 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? LOT NUMBER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY ON AN UNKNOWN DATE AND CONTINUOUS, BARBED VERTICAL SUTURE WAS USED. BLEEDING WAS FOUND FROM WOUNDCHEK AFTER THE SURGERY. COMPRESSION HEMOSTASIS WAS PERFORMED, AND NYLON WAS USED TO REINFORCE. THE PATIENT IS STABLE AND DISCHARGED FROM THE HOSPITAL. THE DOCTOR CONSIDERS THAT THE PATIENT WAS TAKING THE WARFARIN THAT¿S WHY THERE WAS BLEEDING. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472992 SFXSPI PDS+ UNI VIO 18IN 4-0 SA PS-4 PMP SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW ETHICON INC. 10705031240889

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention