BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOBALLOON DIL-XL

    MDR report key: 24143698 · Received January 22, 2026

    Report

    Report Number
    9611612-2026-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 15, 2025
    Report Date
    February 16, 2026
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    GCJ
    UDI-DI
    04048223133026
    PMA / PMN Number
    K090631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IRN# (B)(4) INCIDENT OCCURRED IN GERMANY. MANUFACTURER AWARENESS DATE OF REPORTABILITY: 2026-01-05. PRECHECK OF COMPLAINT DOES NOT INDICATE ANY ADVERSE CONCLUSION. INVESTIGATIONS ARE ONGOING. WHEN NEW INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY.

    Additional Manufacturer Narrative · 0

    IRN# (B)(4). INCIDENT OCCURRED IN GERMANY. MANUFACTURER AWARENESS DATE OF REPORTABILITY: 2026-01-05. PRECHECK OF COMPLAINT DOES NOT INDICATE ANY ADVERSE CONCLUSION. INVESTIGATIONS ARE ONGOING. WHEN NEW INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SENT TO THE AGENCY. UPDATE 2026-02-16: UPDATE OF INVESTIGATION RESULTS AND CORRESPONDING IMDRF CODES. THIS CASE IS CONSIDERED AS CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE AN UPDATE WILL BE SEND TO THE AGENCY.

    Description of Event or Problem · 0

    IRN#(B)(4) INCIDENT OCCURRED IN GERMANY. BALLOON BURST - RUPTURED.

    Description of Event or Problem · 0

    IRN# (B)(4). INCIDENT OCCURRED IN GERMANY. BALLOON BURST - RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205814 ECOBALLOON DIL-XL ECOBALLOON DIL-XL GCJ PAJUNK GMBH MEDIZINTECHNOLOGIE 1600 04048223133026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other