BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMA CARE

    MDR report key: 384282 · Received March 6, 2002

    Report

    Report Number
    MW4003227
    Event Type
    Injury
    Date Received
    March 6, 2002
    Date of Event
    February 25, 2002
    Manufacturer
    PROCTER & GAMBLE PAPER PRODUCT CO
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT USED THIS OTC THERAPEUTIC HEAT WRAP FOR PAIN RELIEF AND MUSCLE RELAXATION WHICH IS SUPPOSED TO LAST 8 HRS. COMPLAINANT SAID THAT THEY USED THE WRAP FOR A FEW WEEKS WITH NO PROBLEMS. THEN EARLY MONDAY MORNING IN 2002, COMPLAINANT USED ONE, AND COMPLAINANT HAD SEVERE BURNING OF THEIR TOP LAYER OF SKIN. COMPLAINANT REMOVED IT ABOUT 7:00 AM THAT MONDAY AND SAID THEY HAD TO GO TO THE ER. COMPLAINANT REPORTED THE INJURY TO THE CO. A REP CALLED THEM BACK FROM CO AND SAID IF COMPLAINANT DIDN'T HAVE INSURANCE, THEY WOULD TAKE CARE OF HOSP BILL. COMPLAINANT SAID AS THEY WERE IN SUCH PAIN THEY COULDN'T WEAR A BRACE WAS SUPPOSED TO WEAR; THEREFORE, COMPLAINANT COULDN'T GO ANYWHERE AND ASKED IF THEY COULD HELP WITH OTHER EXPENSES. HE SAID ALL THEY WOULD PAY FOR ARE HOSP AND DR BILL. HE'S TO MAIL THEM INFO. SPOKE WITH REP IN THE CO. HE SAID HE DIDN'T HAVE ANY INFO ON ANY SIMILAR COMPLAINTS. HE SAID SOMEONE FROM REGULATORY AFFAIRS WOULD CALL BACK RE THIS. RECEIVED A CALL FROM ASSOCIATE DIR OF REGULATORY AFFAIRS OF THE FIRM, AND REGULATORY AFFAIRS MGR. THEY STATED THAT THIS IS AN APPROVED DEVICE 510 K # 953442. FDA CLASSIFICATION NAME, HOT OR COLD DISPOSAL PACK. APPROVED IN 1995. NATIONAL DISTRIBUTION MADE IN 1/02. DEVICE CLASS I. PRODUCT CODE IMD, 21CFR 890.5710. CDRH PHYSICAL MEDICINE DEVICE. THEY STATED THAT THEY'D HAD A FEW CALLS FROM CONSUMERS SAYING THEY FEEL LIKE THEY'VE BEEN BURNED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/4/02: BECAUSE THE CONSUMER DID NOT RETURN THE PRODUCT, AND DID NOT PROVIDE A LOT NUMBER, IT IS IMPOSSIBLE TO EXAMINE THE SPECIFIC PRODUCT USED OR TO INVESTIGATE RETAINS FOR THAT LOT. IF THE PRODUCT HAD BEEN RETURNED, MFR WOULD HAVE CONDUCTED A PHYSICAL EXAMINATION OF THE WRAP TO DETERMINE IF ANY OF THE COMPONENTS WERE DAMAGED OR DEFECTIVE. WITH THE LOT NUMBER, MFR WOULD HAVE INVESTIGATED WHETHER IT HAD RECEIVED OTHER COMPLAINTS ABOUT THAT LOT. MFR'S MARKET EXPERIENCE AND EXTENSIVE SAFETY TESTING TO DATE INDICATES THAT REDNESS OR BURNS ARE VERY RARE. LABELING INFO, INTENDED TO HELP MINIMIZE THIS TYPE OF ISSUE, FOLLOWS. SOME CONSUMERS, DUE TO THEIR OWN UNDERLYING HEALTH CONDITIONS, MAY NEED TO AVOID USE OR MODIFY USE. LABELING IS USED TO EDUCATE CONSUMERS ABOUT POSSIBLE SKIN SENSITIVITIES, INCLUDING MILD BURNS, IF DIRECTIONS TO MONITOR SKIN OR MODIFY USE ARE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMA CARE THERAPEUTICAL HEAT WRAP IMD PROCTER & GAMBLE PAPER PRODUCT CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *