BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIOBALLOON URO

    MDR report key: 21924223 · Received April 29, 2025

    Report

    Report Number
    9611612-2025-00013
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 29, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    GCJ
    PMA / PMN Number
    K090631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# (B)(4). INCIDENT OCCURRED IN SOUTH AFRICA: THIS INCIDENT DID NOT TAKE PLACE IN THE USA, BUT AS CO-REPORTED. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN SOUTH AFRICA: WHEN THE SURGEON WAS READY TO USE THE ANCHOR SYSTEM (1284-70-11S), THE BALLOON WAS FAULTY AND DID NOT INFLATE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476993 VARIOBALLOON URO VARIOBALLOON URO _ LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ PAJUNK GMBH MEDIZINTECHNOLOGIE 1283-70-11S 1523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other