BEUDAMED
    FDA Adverse Event Other Summary report: N

    REMINGTON MEDICAL DRAINAGE BAG

    MDR report key: 416959 · Received September 5, 2002

    Report

    Report Number
    1056553-2002-00001
    Event Type
    Other
    Date Received
    September 5, 2002
    Date of Event
    August 2, 2002
    Report Date
    September 2, 2002
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT'S HUSBAND TELEPHONED REMINGTON, INC. ON AUGUST 5, 2002 ALLEGING THAT ONE OF THE COMPANY'S DRAINAGE BAGS (MODEL 600-D) FAILED TO DRAIN. PT HAD UNDERGONE NEPHROSTOMY SURGERY IN 2002. A REMINGTON MEDICAL, INC. DRAINAGE BAG WAS ATTACHED TO CATHETER TUBING FROM THE PT'S KIDNEY. THE SPOUSE INDICATED THAT SPOUSE LEFT PT AT THE HOSPITAL IN THE RECOVERY ROOM SO THAT SPOUSE COULD GO HOME TO LET THEIR DOG OUT. PT CALLED SPOUSE ON A TELEPHONE FROM THE RECOVERY ROOM AND TOLD SPOUSE THAT THEY WERE IN PAIN. SPOUSE RUSHED BACK TO THE HOSPITAL, BROUGHT THE PROBLEM TO THE ATTENTION OF THE CAREGIVERS, THE BAG WAS REPLACED AND THE FLUID FLOWED INTO THE NEW BAG. AT THIS POINT THE SPOUSE TOOK POSSESSION OF THE BAG AND WOULD NOT RELINQUISH TO THE HSPITAL STAFF. CONSEQUENTLY CO HAS NOT BEEN ABLE TO INSPECT THE BAG OR DETERMINE THE LOT NUMBER OF MFR. THE CO CALLED THE HOSPITAL AND SPOKE WITH THE RISK MGR. RISK MGR'S DETAIL OF THE INCIDENT WAS SOMEWHAT DIFFERENT FROM THE SPOUSE'S. PT TOO, WAS ATTEMPTING TO RETRIEVE THE BAG BUT THE SPOUSE TOOK THE BAG HOME AND STORED IT IN THE FREEZER. THE RISK MGR WAS EXPECTING SPOUSE TO MEET THEM AT THE HOSPITAL SOMETIME AROUND 8/7/02. PT AGREED TO CALL REMINGTON MEDICAL, INC. WITH A REPORT OF THAT MEETING. THE CO HAS NOT HEARD FROM PT AND CO HAS LEFT 5 MESSAGES (TWICE ON 8/5, 8/21, 8/30, AND 9/5) IN THEIR VOICE MAIL ASKING PT TO CALL THE CO. AS YET, PT HAS NOT RESPONDED. ON 8/12/02 REMINGTON MEDICAL, INC. CALLED THE SPOUSE TO ONCE AGAIN ASK FOR THE BAG. THE SPOUSE REFUSES TO RETURN THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMINGTON MEDICAL DRAINAGE BAG DRAINAGE BAG LRO REMINGTON MEDICAL, INC. 600-D UNABLE TO DETERMINE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other