BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4359520 · Received December 9, 2014

    Report

    Report Number
    3003312341-2014-00015
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 11, 2014
    Report Date
    December 9, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K101705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLOWER HOSE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHARP METAL WIRE WAS PROTRUDING FROM THE BLOWER HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796952 MISTRAL-AIR PLUS (115V) BLOWER DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1