BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOUR CARVING BLOCK

    MDR report key: 278568 · Received May 18, 2000

    Report

    Report Number
    2030583-2000-00001
    Event Type
    Other
    Date Received
    May 18, 2000
    Date of Event
    May 12, 2000
    Report Date
    May 18, 2000
    Manufacturer
    ALLIED BIOMEDICAL CORP.
    Product Code
    MIB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT INITIALLY IMPLANTED WITH DEVICE IN 2000 FOR AUGMENTATION IN THE LEG. DOCTOR THOUGHT DEVICE HAD MOVED AND REPOSITIONED DEVICE IN 2000. IN 2000, DOCTOR EXPLANTED DEVICE AND REPLACED IT WITH A LARGER SIZE. DOCTOR CLAIMS DEVICE IS INCORRECT MEASUREMENT AS STATED ON LABELING. PT UNDERWENT 2ND SURGERY FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CARVING BLOCK SILICONE CARVING BLOCK MIB ALLIED BIOMEDICAL CORP. NA A2826/1348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other