BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUELLER

    MDR report key: 768854 · Received October 10, 2006

    Report

    Report Number
    2110420-2006-00001
    Event Type
    Injury
    Date Received
    October 10, 2006
    Date of Event
    August 22, 2006
    Report Date
    August 29, 2006
    Manufacturer
    MUELLER SPORTS MEDICINE, INC.
    Product Code
    IME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CAUTION STATEMENT ON THE REUSABLE COLD/HOT PACK READ AS FOLLOWS: WHEN COLD-HOT PACK IS BROUGHT TO DESIRED TEMPERATURE, NEVER APPLY TO SKIN WITHOUT A COVER OR WRAPPING. IF COLD OR HEAT IS UNCOMFORTABLE, REMOVE FOR A FEW MOMENTS, THEN REAPPLY TO AREA. IF YOU HAVE A CIRCULATORY PROBLEM, CONSULT A PHYSICIAN BEFORE USING COLD-HOT PACK. CUSTOMER SHOULD HAVE MONITORED IF THE HEAT WAS UNCOMFORTABLE; HE MAY HAVE BEEN IMPAIRED FROM MEDICATIONS. IT IS UNKNOWN IF A PHYSICIAN WAS CONSULTED AS IT IS KNOWN THE CUSTOMER HAS CIRCULATORY ISSUES. CUSTOMER FELL ASLEEP AND DID NOT MONITOR, EVEN IN THE FIRST FEW MINUTES OF APPLICATION, TO CHECK IS HEAT APPLIES WAS OK.

    Description of Event or Problem · 1

    A NURSE VISITED A GENTLEMAN WHO USED A REUSABLE COLD/HOT PACK A WEEK PREVIOUSLY. SHE NOTICED A REDDENED, SCABBED AREA BELOW HIS RIGHT KNEE. HE RELATED THAT A WEEK AGO, HE USED THE REUSABLE COLD/HOT PACK FOLLOWING THE DIRECTIONS FOR HOT USE USING BOILING WATER TO HEAT THE PACK. HE PLACED THE PACK IN THE POCKET OF A SPORTS WRAP, PLACED THE WRAP ON HIS KNEE AND FELL ASLEEP. WHEN HE WOKE UP, HE NOTICED A LARGE BLISTER WHICH BROKE OPEN SEVERAL DAYS LATER. THE NURSE RECOMMENDED HE BE SEEN AT AN URGENT CARE CENTER. CUSTOMER WAS TOLD HE HAD A STAGE 2 BURN AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MUELLER IMD; REUSABLE COLD/HOT PACK + SPORTS WRAP IME MUELLER SPORTS MEDICINE, INC. 330104 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention SPORTS WRAP + HOT PACK FOR LEFT KNEE AND BACK.