BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECUT ADENOID CURETTE

    MDR report key: 2194393 · Received December 21, 2007

    Report

    Report Number
    1017294-2006-00034
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Product Code
    KBJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH FORM WAS RECEIVED, HOWEVER, ONLY FRONT PAGE, PAGE 2 WAS NOT RECEIVED FROM USER FACILITY. NO USER FACILITY REGISTRATION NUMBER ON MEDWATCH FORM. USER FACILITY MEDWATCH FORM ATTACHED. INVESTIGATION RESULT: THE CURETTE WAS RETURNED FOR EVAL. A VISUAL EXAMINATION OF THE DEVICE FOUND THERE WAS NO BLADE INSTALLED IN THE CURETTE. IN ADDITION, THE SLOT WHERE THE BLADE SHOULD BE INSTALLED HAD EXCESSIVE FLASH (EXCESS MATERIAL) ROLLED OVER WERE THE BLADE SHOULD HAVE BEEN INSERTED. THIS EXAMINATION FINDS THAT THE BLADE MAY NOT HAVE BEEN INSTALLED. A REVIEW OF THE OTHER COMPLAINTS SHOWED THERE IS NO OTHER COMPLAINTS FOR THIS DEVICE AND TYPE OF FAILURE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURECUT ADENOID CURETTE ADENOID CURETTE, SIZE 2 KBJ NA

    Patients

    Seq Age Sex Outcome Treatment
    1