BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANSELL LATEX GLOVE, UNOMEDICAL LATEX FOLEYCATH

    MDR report key: 3234137 · Received November 22, 2006

    Report

    Report Number
    1420054-2006-00001
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    September 7, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ANSELL
    Product Code
    LYY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    LSL 1620M, A CONVENIENCE KIT INCLUDES 5 PREP BALLS, UNDERDRAPE, FENESTRATED DRAPE, POWDER FREE NITRILE GLOVES, LUBE JELLY, STERILE WATER 10 CC PREFILL SYRINGE FOR CATHETER INFLATION ONLY, PLASTIC FORCEPS, 16 FR SILICONE ELASTOMER COATED FOLEY CATHETER, 2000 CC DRAIN BAG, SPECIMEN CONTAINER, PVP SOLUTION, CSR WRAP. (B)(6) OF (B)(6) MEDICAL CENTER SAID THAT THE ALLERGIC REACTION WAS FROM EITHER THE GLOVES OR THE CATHETER THAT WERE IN CONTACT WITH THE PATIENT AT THE TIME OF ALLERGIC REACTION. THE LATEX FOLEY CATHETER IS MANUFACTURED BY UNOMEDICAL WHICH IS A PART OF THE LSL KIT. THE LSL 1620M KIT IS APPROPRIATELY LABELED WITH THE LATEX CAUTION STATEMENT. THIS KIT ALSO INCLUDES NITRILE GLOVES WHICH WERE NOT USED BY THE HEALTH PROFESSIONAL. THE HEALTH PROFESSIONAL WAS USING LATEX GLOVES MANUFACTURED AND SUPPLIED DIRECTLY BY ANSELL, WHICH WERE NOT A PART OF THE LSL KIT. A COPY OF THIS REPORT WILL BE FORWARDED TO UNOMEDICAL WHO IS THE MANUFACTURES OF CATHETER (INCLUDED IN THE LSL KIT) WHOSE DEVICE WAS POTENTIALLY INVOLVED WITH THIS EVENT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    AS PER (B)(6) OF (B)(6) MEDICAL CENTER LOCATED IN (B)(6), THE PATIENT HAD LATEX ALLERGIC REACTION TO ONE OF THE DEVICES BEING USED - ANSELL LATEX GLOVES #5785004 (MANUFACTURED BY ANSELL - NOT A PART OF LSL KIT) AND/OR THE LATEX CATHETER MANUFACTURED BY UNOMEDICAL# 71-2262 (PART OF LSL KIT #1620M). LSL KIT #1620M WAS APPROPRIATELY LABELLED WITH LATEX CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANSELL LATEX GLOVE, UNOMEDICAL LATEX FOLEYCATH LATEX GLOVES, LATEX FOLEY CATHETER LYY ANSELL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening