BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 7764054 · Received August 8, 2018

    Report

    Report Number
    9618003-2018-00997
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROTECTOR, OSTOMY; EXE; : (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STARTER HOLE ISN'T CENTRAL. NO PHOTOS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606675 NATURA NOT APPLICABLE EXE CONVATEC DOMINICAN REPUBLIC INC 402204 8A04920

    Patients

    Seq Age Sex Outcome Treatment
    1