BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON APPLICATOR KIT

    MDR report key: 24740246 · Received March 31, 2026

    Report

    Report Number
    3015232217-2026-00008
    Event Type
    Injury
    Date Received
    March 31, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    JAD
    UDI-DI
    00858012005311
    PMA / PMN Number
    K090914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT DEVELOPED MULTIPLE INTRACEREBRAL HEMORRHAGES SHORTLY AFTER SURGERY AND HAS BEEN ON MECHANICAL VENTILATION IN THE INTENSIVE CARE UNIT FOR THE PAST THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805227 BALLOON APPLICATOR KIT BALLOON APPLICATOR, 3-4 CM SPHERICAL JAD ELEKTA SOLUTIONS AB 720788 2435101 00858012005311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L