BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY HOT SMART RELIEF TENS BACK PAIN THERAPY

    MDR report key: 6805849 · Received August 18, 2017

    Report

    Report Number
    1022556-2017-00005
    Event Type
    Injury
    Date Received
    August 18, 2017
    Report Date
    August 4, 2017
    Manufacturer
    CHATTEM
    Product Code
    NUH
    PMA / PMN Number
    K131159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON 04-AUG-2017 FROM PATIENT'S WIFE. THIS CASE INVOLVES A MALE PATIENT OF UNKNOWN AGE, WHO ENDED UP WITH 2 BLISTERS ON HIS BACK AFTER RECEIVING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY). PAST DRUGS, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2017, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/ BATCH NUMBER AND EXPIRY DATE: UNKNOWN) FOR HURTING BACK. IT WAS REPORTED THAT PATIENT USED SMART RELIEF TENS THERAPY FOR A BIT THAT DAY ((B)(6) 2017) AND HE ENDED UP WITH 2 BLISTERS ON HIS BACK (ONSET DATE AND LATENCY: UNKNOWN). ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. EVENT OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. QA REVIEW FINDINGS: ALL RETAINS ARE EXAMINED FOR CORRECT PACKAGING, SEAL, MISSING COMPONENTS, WORKING CONTROL UNIT, LEGIBILITY OF LOT NUMBERS /EXPIRATION DATE, CORRECT LABEL AND FOREIGN MATTER. NO ANOMALIES WERE FOUND THAT COULD CONTRIBUTE TO THIS COMPLAINT. DEVICE RETURN IS EXPECTED; IF/WHEN IT IS RETURNED FURTHER INVESTIGATION MAY BE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE QUALITY DEPARTMENT ON 07-AUG-2017: QA REVIEW FINDINGS WERE ADDED. TEXT UPDATED ACCORDINGLY.

    Description of Event or Problem · 1

    INITIAL INFORMATION REGARDING THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6)2017 FROM PATIENT'S WIFE. THIS CASE INVOLVES A MALE PATIENT OF UNKNOWN AGE, WHO ENDED UP WITH 2 BLISTERS ON HIS BACK AFTER RECEIVING TREATMENT WITH SMART RELIEF TENS THERAPY (ICY HOT SMART RELIEF TENS BACK PAIN THERAPY). PAST DRUGS, MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6)2017, THE PATIENT STARTED THERAPY WITH SMART RELIEF TENS THERAPY AT AN UNSPECIFIED FREQUENCY (LOT/ BATCH NUMBER AND EXPIRY DATE: UNKNOWN) FOR HURTING BACK. IT WAS REPORTED THAT PATIENT USED SMART RELIEF TENS THERAPY FOR A BIT THAT DAY ((B)(6)2017) AND HE ENDED UP WITH 2 BLISTERS ON HIS BACK (ONSET DATE AND LATENCY: UNKNOWN). ACTION TAKEN: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. EVENT OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT: A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH LOCAL PTC NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584975 ICY HOT SMART RELIEF TENS BACK PAIN THERAPY TRANSCUTANEOUS NERVE STIMULATOR NUH CHATTEM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other