BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS ALCOHOL PREP PAD

    MDR report key: 1001440 · Received February 19, 2008

    Report

    Report Number
    MW5005610
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 19, 2008
    Manufacturer
    TRIAD/NOVATION
    Product Code
    LKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WE HAD AN ALCOHOL PREP PAD CONTAMINATED WITH AN INSECT ON FRIDAY. IT WAS LAMINATED BETWEEN THE TWO LAYERS OF THE PAD. THE PRODUCT WAS DISTRIBUTED BY DISTRIBUTOR. THE DISTRIBUTOR HAS INITIATED AN INVESTIGATION. THE MFR PRODUCT NO. NDC50730-3002-9 CAT NO V9105. WE HAVE IDENTIFIED 3 LOT NUMBERS IN USE IN THAT DEPT; 7D106, 7L155 AND 7J189. THE BOXES IN USE HAD THE TOP LIDS TORN OFF AND WERE LACKING LOT NUMBERS. THE PRODUCT DID NOT COME IN CONTACT WITH THE PT. I HAVE RETAINED THE CONTAMINATED PRODUCT. A DIGITAL PHOTO IS AVAILABLE. DOSE OR AMOUNT: SINGLE USE. FREQUENCY: NA, ROUTE: TOP. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: REDUCTION OF BACTERIAL LOAD ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAPLUS ALCOHOL PREP PAD NONE LKB TRIAD/NOVATION UNK
    2 NONE LKB TRIAD GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 YR