BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA

    MDR report key: 9442773 · Received December 9, 2019

    Report

    Report Number
    9618003-2019-16817
    Event Type
    Injury
    Date Received
    December 9, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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

    THE END USER REPORTED THAT HE IS A WELDER SO WHEN HE BENT OVER HIS STOMA, IT WOULD RUB ON THE FLANGE AND HE STATED THAT IT APPEARED TO HAVE CUT INTO HIS STOMA FROM APPROXIMATELY 900-300 O'CLOCK POSITION. HE HAD A SMALL AMOUNT OF BLEEDING FROM THIS AREA. THEREAFTER, HE STOPPED USING THIS WAFER AND THE AREA RESOLVED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230130 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 125264

    Patients

    Seq Age Sex Outcome Treatment
    1