BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL OVATIONS 314 G

    MDR report key: 2143660 · Received December 27, 2007

    Report

    Report Number
    1718371-2007-00001
    Event Type
    Injury
    Date Received
    December 27, 2007
    Date of Event
    November 1, 2007
    Report Date
    December 26, 2007
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS OF A SKIN RASH. THIS WAS THE FIRST AND ONLY REPORT OF A RASH SUSPECTED TO BE CAUSED BY CONTACT WITH THE ARM PADS. MORE THAN 10,000 PAIR OF GEL ARM PADS HAVE BEEN USED STARTING MORE THAN 5 YEARS AGO. AFTER THE INITIAL REPORT OF SUSPECTED RASH, AND SOME TIME AFTER REMOVAL FROM THE ARM PAD, USER'S FAMILY REPORTED THEIR SUSPICION THAT THE ARM PAD MAY HAVE CAUSED A (B)(6) INFECTION. FINALLY, THE USER'S FAMILY REPORTED THEIR BELIEF THAT THE USE OF THE ARM PAD MAY HAVE LED TO LIVER AND OR KIDNEY PROBLEMS. OUR INVESTIGATION CONTINUES, AND WE HAVE AGAIN REQUESTED RETURN OF THE ARM PAD TO FACILITATE OUR INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED TO THE MANUFACTURER IN A SERIES OF COMMUNICATIONS BY (B)(4), ONE OF THEIR CLIENTS - (B)(6) - BROKE OUT IN A RASH ON HIS ARM. THE CLIENT'S FAMILY FELT IT WAS CAUSED BY EXPOSURE TO A GEL ARM PAD THEY HAD RECENTLY INSTALLED ON (B)(6)'S WHEELCHAIR. THEY ALSO FELT THAT IT "SMELLED FUNNY." SUBSEQUENT COMMUNICATIONS INDICATED THEY FELT THAT EXPOSURE TO THE ARM PAD OR THE RASH THEY FELT WAS CAUSED BY EXPOSURE TO THE ARM PAD, CAUSED A (B)(6) INFECTION. THEY ALSO FELT THAT LIVER PROBLEMS AND POSSIBLY OTHER PROBLEMS WERE OTHER POSSIBLE RESULTS OF EXPOSURE TO THE ARM PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL OVATIONS 314 G GEL ARM PAD 3 1/2" X 14" KNN 314 G Y4014A-1-24-07

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization