BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED FS-2

    MDR report key: 19819200 · Received July 24, 2024

    Report

    Report Number
    2210968-2024-07574
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031119970
    PMA / PMN Number
    K033746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING RESPONSE WAS OBTAINED: 1. PLEASE CLARIFY HOW MANY DEVICES WAS USED ON THIS SINGLE PROCEDURE. 1 BOX LOT AU9218 2. IF THERE ARE MULTIPLE PATIENT EVENTS, ASK: NOT CONCERNED 3. PROVIDE THE SPECIFIC NUMBER OF PATIENT EVENTS:/ 4. DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES?/ 5. WHAT IS THE TOTAL NUMBER OF PROCEDURES?/ 6. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S)./ TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED D4: UDI: THE MANUFACTURING AND EXPIRATION DATES ARE CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/6/2024. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT DENTAL SURGERY ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE STRAND IS FRAYING AND BROKE. AN AVERAGE OF 1 OUT OF 3 WIRES CAUSED A PROBLEM DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349666 VICRYL RAP UND 75CM M1.5 USP4/0 SGLE ARMED FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU9218 10705031119970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown