BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINCH KYPHOPLASTY BALLOON

    MDR report key: 15040217 · Received July 18, 2022

    Report

    Report Number
    3010899956-2022-00001
    Event Type
    Malfunction
    Date Received
    July 18, 2022
    Date of Event
    June 14, 2022
    Report Date
    June 27, 2022
    Manufacturer
    G-21S.R.L.
    Product Code
    HRX
    PMA / PMN Number
    K172214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 A CUSTOMER COMPLAINED THAT 1 OF THE G21 11G 15MM BALLOONS RUPTURED DURING EXPANSION IN SURGERY. SAME SITUATION, ON (B)(6) 2022, 2 OF THE SAME BALLOONS OF THE SAME LOT NUMBER RUPTURED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2890946 WINCH KYPHOPLASTY BALLOON KYPHOPLASTY BALLOON CATHETER HRX G-21S.R.L. 900027 20220100073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown