BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT 3 INCH ROLL

    MDR report key: 1726736 · Received June 14, 2010

    Report

    Report Number
    MW5016349
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    April 20, 2010
    Report Date
    June 4, 2010
    Manufacturer
    CHATTEM INC
    Product Code
    OMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPLIED PRODUCT PER PRESCRIBED LABEL. WHEN REMOVING PRODUCT, THE PRODUCT PROCEEDED TO REMOVE 6 INCHES OF SKIN ALMOST DOWN TO THE BONE. INJURY BLED PROFUSELY FOR APPROX 3-4 DAYS. I WAS INFORMED BY (B) (4) THAT THEY HAD TO ALSO FILE A REPORT BECAUSE OF INJURY SEVERITY. APPLIED ICY HOT 3 INCH MEDICATED ROLL AS PRESCRIBED. WHEN REMOVING THE PRODUCT, IT REMOVED 6 INCHES OF MY SKIN & A GREAT PORTION OF BODY MATTER. (PHOTO'S WERE SENT TO (B) (4) APPROX 1 1/2 WEEKS AFTER INCIDENT) IT WAS NOT IN MY HOME STATE WHEN THIS OCCURRED. NOT HAVING MEANS TO GO TO A HOSPITAL, I APPLIED A FIELD DRESSING FOR THE NEXT 3-4 DAYS TO AVOID INFECTION OR MANY OTHER COMPLICATIONS. (B) (4) ADVISED ME THEY ALSO FILED A REPORT WITH THE FDA BECAUSE MY INJURIES REQUIRED OR WERE SUFFICIENT ENOUGH TO FILE A CLAIM. DOSE OR AMOUNT: 6 INCHES. FREQUENCY: ONCE. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT 3 INCH ROLL ICY HOT OMW CHATTEM INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other