BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 30IN 2-0 S/A V-6

    MDR report key: 11418051 · Received March 4, 2021

    Report

    Report Number
    2210968-2021-02005
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER QAMPML / W982840, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DID THE PATIENT EXPERIENCE ANY ADVERSE CONSEQUENCES DUE TO THIS ISSUE? NO. WHAT WAS BEING DONE WHEN THE SUTURE BROKE (REMOVAL FROM PACKAGE / DURING PASSAGE THROUGH TISSUE/ DURING TYING? UNKNOWN. WAS THE NEEDLE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE? YES. WHAT TISSUE/LOCATION WAS SUTURING WHEN PULL OFF OCCURRED? UNKNOWN. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THIS SUTURE NEEDLE PULL OFF EVENT? NO. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WERE FOUND SEPARATED FROM SWAGE POINT WHEN THE SUTURE FOIL OPENED DURING SURGERY. THERE WERE NO PIECES LEFT IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315048 VCL CT BRD VIO 30IN 2-0 S/A V-6 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. QAMPML

    Patients

    Seq Age Sex Outcome Treatment
    1