BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACURETTE, CURVED 10MM 10/PKG

    MDR report key: 536594 · Received March 19, 2004

    Report

    Report Number
    2124979-2004-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Date of Event
    February 10, 2004
    Report Date
    March 17, 2004
    Manufacturer
    ACMI CORPORATION
    Product Code
    HHK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE, THE DR NOTICED THAT THE VAC WAS CRACKED AND BROKEN, DISCONTINUED USE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACURETTE, CURVED 10MM 10/PKG VACUUM CURETTE HHK ACMI CORPORATION 21553 VC00294

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN