BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE #1: ALLEGIANCE HEALTHCARE CORP. PREP TR

    MDR report key: 146814 · Received December 30, 1997

    Report

    Report Number
    146814
    Event Type
    Malfunction
    Date Received
    December 30, 1997
    Date of Event
    July 9, 1997
    Report Date
    July 18, 1997
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP. CONVERTORS/CUSTOM STERILE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD PREPPED RIGHT LEG AFTER REMOVAL OF A.O. EXTERNAL FIXATOR. HE THEN USED Q-TIPS X2 FROM PREPSET WITH H2O2 TO CLEAN OUT PIN HOLES. BOTH Q-TIPS COTTON PARTS WERE RETAINED IN THE PIN HOLES. THERE WAS ATTEMPTED REMOVAL POST SURGERY OF THE Q-TIP PORTIONS WHICH WAS UNSUCCESSFUL. DURING THE ATTEMPT TO REMOVE TIPS ANOTHER INSTRUMENT BROKE & WAS RETAINED IN BONE. CODMAN RIGHT MICRO HARDY ENUCLEATOR. REPORT TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1: ALLEGIANCE HEALTHCARE CORP. PREP TR APPLICATOR TIP FROM EXTREMITY PACK KXF ALLEGIANCE HEALTHCARE CORP. CONVERTORS/CUSTOM STERILE A4465 PREP TRAY 618314

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other INSTRUMENT (CODMAN) ALSO RETAINED IN BONE.| ADD'L SURGERY TIME TO RETRIEVE UNSUCCESSFUL & 2ND