BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8864670 · Received August 6, 2019

    Report

    Report Number
    9618003-2019-04975
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THAT 111 PIECES HAVE "OFF CENTER STARTER HOLE". THESE PRODUCTS WERE NOT USED BY ANY PATIENTS, NO HARM REPORTED. NO PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS SUBMITTED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657547 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413181 8L02242

    Patients

    Seq Age Sex Outcome Treatment
    1