BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z-MED II

    MDR report key: 236715 · Received August 20, 1999

    Report

    Report Number
    2523676-1999-00024
    Event Type
    Injury
    Date Received
    August 20, 1999
    Date of Event
    June 22, 1999
    Report Date
    August 17, 1999
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 14, 1999, ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY WHICH INDICATED THAT THE BALLOON BURST AT 15 ATM, AND NOT AT 12 ATM AS ORIGINALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED II ZMED II PERIPHERAL BALLOON DILATION CATHETER LIT B. BRAUN MEDICAL, INC. PDZ631 ZZ-0145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention