BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAHL FULL-BODY THERAPEUTIC MASSAGER

    MDR report key: 9800313 · Received March 6, 2020

    Report

    Report Number
    MW5093566
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    February 9, 2020
    Report Date
    March 4, 2020
    Manufacturer
    WAHL CLIPPER CORPORATION
    Product Code
    ISA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIRD DEGREE BURN; I HAD EXTREME STABBING PAIN IN MY LEFT FOOT FOR 3 DAYS. I APPLIED THE WAHL MASSAGER WITH DEEP HEAT ATTACHMENT. I PLACED IT ON THE BOTTOM OF MY FOOT FOR LESS THAN A MIN OF MASSAGE. I THEN TURNED ON THE HEAT SWITCH AND PLACED IT ON THE TOP OF MY FOOT WITH HEAT AND MASSAGE. IN LESS THAN 2 MINS, THE HEATED MASSAGER PULLED OFF THE SKIN AND LEFT AN OPEN BURN ON THE TOP OF MY FOOT. AFTER THIS EVENT, I TESTED THE TEMPERATURE OF THE HEATED METAL PLATE AND IT WAS 126 DEGREES. FDA SAFETY REPORT ID#S: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264577 WAHL FULL-BODY THERAPEUTIC MASSAGER MASSAGER, THERAPEUTIC, ELECTRIC ISA WAHL CLIPPER CORPORATION 4295A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R ADMELOG | ATORVASTATIN | BASAGLAR| DORZOLOMIDE| DOXYCYCLINE| GABAPENTIN | GLIPIDIZE | LEVOFLOXACIN | METFORMIN | TRAVAPROST| VITAMIN B12