BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPINE LEG BAG LARGE 32OZ

    MDR report key: 1293102 · Received January 21, 2009

    Report

    Report Number
    2183558-2009-00006
    Event Type
    Injury
    Date Received
    January 21, 2009
    Date of Event
    October 1, 2008
    Report Date
    October 29, 2008
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FAQ
    PMA / PMN Number
    K934052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE LEG BAGS WERE RECEIVED FOR EVAL. EXAMINATION AND TESTING OF THE RETURNED PRODUCTS CONFIRMED THE COMPLAINT AS REPORTED WITH ONE OF THE LEG BAGS. WHEN WATER WAS INTRODUCED INTO THE THREE BAGS, WATER FLOWED FREELY INTO TWO BAGS, BUT DID NOT FLOW INTO ONE BAG AS EXPECTED. THE BAG WAS FURTHER EXAMINED AND IT WAS NOTED THAT THE ANTI-REFLUX VALVE WAS NOT WORKING PROPERLY. PERSONNEL TRIED OPENING THE VALVE AND DID SO MANUALLY. THE MALFUNCTIONING BAG WAS THEN SENT TO THE MFR FOR FURTHER EVAL. RESULTS FROM THAT EXAMINATION INDICATED THAT THE MFR WAS NOT ABLE TO DUPLICATE THE MALFUNCTION, AS THE BAG HAD BEEN MANUALLY OPENED PRIOR TO THE MFR RECEIVING IT. HOWEVER, IT WAS NOTED THAT THE SLIT APPEARED CENTERED AND COMPLETE. THE CONTRACT MFR IS GOING TO PUT ADDITIONAL TESTING IN PLACE AT INCOMING INSPECTION TO VERIFY THE VALVE IS WORKING CORRECTLY. TO DATE, THERE HAVE BEEN NO OTHER COMPLAINTS RECORDED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, AN END-USER REPORTED THAT THE LAST 4 OF THE 68001'S WERE DEFECTIVE, AS URINE WOULD NOT DRAIN IN THEM. THE URINE WOULD COLLECT ON TOP OF THE ANTI-REFLUX VALVE (3 OF THE DEFECTIVE PRODUCTS WERE LOT 08119 AND 1 WAS LOT 08182) SO IT MAY BE DEFECTIVE VALVES. THE PT'S WIFE TOOK HIM TO ER BECAUSE OF CONCERN THAT THE FOLEY WAS NOT IN OR NOT WORKING PROPERLY. ONCE AT THE ER, HIS BLADDER WAS DRAINED AND NO KNOWN INJURY WAS REPORTED. PT WENT HOME FROM HOSP AND STILL HAD DRAINAGE ISSUES WITH THE BAGS, SO CALLED COLOPLAST TO SEE IF THEY WERE CONNECTING THE BAG CORRECTLY TO THE FOLEY. WHILE ON THE PHONE, THE WIFE SAID THAT SHE COULD SEE THE URINE IN THE TUBING BUT ONCE SHE DISCONNECTED THE TUBING FROM THE BAG, THE URINE WAS SITTING ON TOP OF THE ANTI REFLUX VALVE AND THEN THERE WAS NORMAL URINE FLOW DRAINING FROM THE FOLEY WHEN DETACHED FROM LEG BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPINE LEG BAG LARGE 32OZ LEG BAG FAQ COLOPLAST MANUFACTURING US LLC 5596001400 08119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention