BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE HOT/COLD COMPRESS, REUSABLE

    MDR report key: 2094543 · Received April 8, 2011

    Report

    Report Number
    9710505-2011-00002
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    October 31, 2010
    Report Date
    February 25, 2011
    Manufacturer
    RAPID-AID CORP.
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFO PROVIDED, IT APPEARED THAT THE PRODUCT WAS ABOUT (B)(6). IT IS UNCLEAR IF THE PRODUCT WAS FROZEN PRIOR TO USE OR NOT, AS PER INSTRUCTIONS NOT TO HEAT UP FROZEN PRODUCT. ALSO, IT IS NOT CLEAR HOW MUCH USE THE PRODUCT HAD INCURRED PRIOR TO THE ISSUE. TEAM WILL CONTINUE TO MONITOR FOR ANY FUTURE COMPLAINTS RELATED TO THIS ISSUE. WE HAVE NOT BEEN ABLE TO GATHER ADD'L INFO. THIS IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER USED THE ACE HOT/COLD PACK, IT BROKE OPEN AND SQUIRTED ONTO HIS SON'S FACE. IT CAUSED BLISTERS TO FORM ON HIS LOWER LEFT CHEEK NEAR HIS JAW. CUSTOMER HAS HAD THE PRODUCT FOR OVER A YEAR AND HAS USED IT AS BOTH HOT AND MOSTLY FOR COLD WITH NO UNDUE EFFECTS. CUSTOMER MICROWAVED GEL PACK FOR 30 SECONDS ON (B)(6) IN THE EVENING. CUSTOMER REMOVED THE GEL PACK AND MASSAGED GEL PACK TO DIFFUSE THE HEAT. WHILE DOING SO, THE GEL PACK SPLIT AND SQUIRTED HOT GEL ONTO THE BOY'S FACE. THEY WASHED WITH COLD WATER TO REMOVE GEL FROM FACE AND THE AREA REDDENED AND STARTED TO BLISTER. PARENTS GAVE ADVIL FOR THE PAIN. CUSTOMER TOOK HIS SON TO THE DOCTOR. THE AFFECTED AREA HAS A SECOND DEGREE BURN WHICH WILL TAKE 6-8 WEEKS TO HEAL. THERE MAY BE PIGMENTATION DISCOLORATION THAT MAY LAST UP TO A YEAR AND HE IS WORRIED ABOUT SCARRING. DURING THE HEALING OF THE BURN, THE SON NEEDS TO KEEP AREA COVERED SO THE SUN DOES NOT AFFECT THE PIGMENTATION ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE HOT/COLD COMPRESS, REUSABLE REUSABLE HOT/COLD COMPRESS IME RAPID-AID CORP. 08147

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR