BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC OSTIUM PUNCH

    MDR report key: 127749 · Received October 17, 1997

    Report

    Report Number
    1418479-1997-00049
    Event Type
    Malfunction
    Date Received
    October 17, 1997
    Date of Event
    September 17, 1997
    Report Date
    September 18, 1997
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    KTF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A ROTATABLE OSTIUM PUNCH WAS IN USE IN A PT'S NASAL CAVITY. DURING THE ANTERIOR ETHMOIDECTOMY PROCEDURE, THE MOVABLE JAW PLACE BROKE OFF. THE METAL OBJECT WAS RETRIEVED WITHOUT DIFFICULTY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC OSTIUM PUNCH PEDIATRIC OSTIUM PUNCH KTF RICHARD WOLF GMBH 8211-651 A-L-U

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR