BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUT 30IN(75CM) 0 BLU

    MDR report key: 17259773 · Received July 5, 2023

    Report

    Report Number
    2210968-2023-04833
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    May 10, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031021051
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 7/5/2023. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: DID 1 SUTURE BREAK IN EACH OF THE 3 PROCEDURES? MORE THAN ONE EXACT NUMBER IS UNKNOWN HOW MANY SUTURE BREAKAGES OCCURRED DURING THE PROCEDURE REPRESENTED IN (B)(4)? EXACT NUMBER IS UNKNOWN WHAT IS THE TOTAL NUMBER OF PRODUCTS INVOLVED IN THIS EVENT? DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? MULTIPLE SEE ANSWER OF DISTRRIBUTOR WHAT IS THE TOTAL NUMBER OF PROCEDURES? IN TOTAL THREE HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). NONE , BUT TO NWE COMPLAINT CREATED IN ADDTION SEE (B)(4) FOR (B)(6), (B)(4) FOR (B)(6). IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, PLEASE CREATE A PRODUCT COMPLAINT FOR EACH EVENT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). DID THE PULL OFF - SUTURE NEEDLE OCCUR? NO. IF YES, HOW MANY SUTURES ARE PULLED OFF? DID THE SUTURE BREAKAGE OCCUR? YES. IF YES, HOW MANY SUTURES ARE BROKEN? IN THREE PROCEDURES WHAT IS THE TOTAL NUMBER OF EVENTS? THREE EVENTS. 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. RELATED REPORTS: 2210968-2023-04831.

    Additional Manufacturer Narrative · 0

    (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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA OPERATION ON (B)(6) 2023 AND SUTURE WAS USED. WE HAD HUMAN OP DAYS ON THE 3RD ON THE 10TH AND ON 24. DURING THE PROCEDURES, WHEN USING THE THREADS (SUTURES IN UMBILICAL AND INGUINAL HERNIA OPERATIONS), THREADS CONSTANTLY BROKE OFF WHEN PULLED AND HAD TO BE RENEWED. THIS IS UNTYPICAL FOR THIS TYPE OF SUTURE SINCE THIS SUTURE HAS ALWAYS BEEN USED FOR SEVERAL YEARS AND OTHERWISE SUTURES HAVE ALMOST NEVER BROKEN DURING MESH IMPLANTATION, SO WE ASSUME A MATERIAL DEFECT. RUPTURE OF THE SUTURE WHEN IT WAS PULLED OUT OF THE BODY WITH ONLY SLIGHT TRACTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930625 PROLENE SUT 30IN(75CM) 0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 8834H RKBEEP 10705031021051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown