BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L/B KIT 1000ML TURNTAP

    MDR report key: 2251903 · Received September 16, 2011

    Report

    Report Number
    2125050-2011-00008
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FAQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SENT OUT FOR TESTING BUT AT THE TIME OF THIS REPORT THE DATA WAS NOT AVAILABLE THEREFORE, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. FOLLOW UP 1: SIXTEEN STRAPS WERE RECEIVED FOR EVALUATION. THE STRAPS WERE SENT TO THE CONTRACT MANUFACTURER FOR INSPECTION AND TESTING. THE CM EXAMINED AND INSPECTED THE SAMPLES AND FOUND THAT THE USER SAID THE ONE THAT CAUSED THE ISSUE WAS A STRAP WITH BLUE AND WHITE BUTTONS ON IT. THE CM PRODUCT ONLY HAS WHITE BUTTONS ON THE STRAP SO IT WAS CONCLUDED THAT THE STRAP CAUSING THE REACTION WAS NOT THEIR PRODUCT. THE CM PROVIDED A CERTIFICATE OF COMPLIANCE TO DECLARE THAT THEIR STRAPS ARE LATEX FREE.

    Additional Manufacturer Narrative · 1

    SAMPLES WERE SENT OUT FOR TESTING BUT AT THE TIME OF THIS REPORT THE DATA WAS NOT AVAILABLE THEREFORE, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. WHEN ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, AN END USER CLAIMS THAT THE BUTTON STRAPS THAT WERE PROVIDED WITH THE BAG MUST CONTAIN LATEX BECAUSE THE STRAPS CAUSED AN ALLERGIC REACTION THAT REQUIRED MEDICAL ATTENTION. AFTER WEARING THE STRAP FOR 1 HOUR IT CAUSED LESIONS ON HIS LEG WHERE THE STRAP WAS IN CONTACT WITH HIS SKIN.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, AN END USER CLAIMS THAT THE BUTTON STRAPS THAT WERE PROVIDED WITH THE BAG MUST CONTAIN LATEX BECAUSE THE STRAPS CAUSED AN ALLERGIC REACTION THAT REQUIRED MEDICAL ATTENTION. AFTER WEARING THE STRAP FOR 1 HOUR IT CAUSED LESIONS ON HIS LEG WHERE THE STRAP WAS IN CONTACT WITH HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L/B KIT 1000ML TURNTAP URINE BAG FAQ COLOPLAST MANUFACTURING US LLC 5084301440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention