BEUDAMED
    FDA Adverse Event Summary report: N

    SILASTIC SPONGE BUCKLE

    MDR report key: 18373 · Received December 13, 1994

    Report

    Report Number
    MW1004418
    Date Received
    December 13, 1994
    Report Date
    December 9, 1994
    Manufacturer
    MIRA, INC.
    Product Code
    HQJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER IMPLANTATION, A PT DEVELOPED AN INFECTION CAUSED BY MYCOBACTERIUM CHELONAE. THE SPONGE WAS REMOVED AND THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC SPONGE BUCKLE HQJ MIRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *