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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAHL CLIPPER CORPORATION WAHL FULL-BODY THERAPEUTIC MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC

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WAHL CLIPPER CORPORATION WAHL FULL-BODY THERAPEUTIC MASSAGER; MASSAGER, THERAPEUTIC, ELECTRIC Back to Search Results
Model Number 4295A
Device Problem Temperature Problem (3022)
Patient Problems Pain (1994); Full thickness (Third Degree) Burn (2696)
Event Date 02/09/2020
Event Type  Injury  
Event Description
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).
 
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Brand Name
WAHL FULL-BODY THERAPEUTIC MASSAGER
Type of Device
MASSAGER, THERAPEUTIC, ELECTRIC
Manufacturer (Section D)
WAHL CLIPPER CORPORATION
MDR Report Key9800313
MDR Text Key182398064
Report NumberMW5093566
Device Sequence Number1
Product Code ISA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number4295A
Device Catalogue Number93342-1002
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/06/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ADMELOG ; ATORVASTATIN ; BASAGLAR; DORZOLOMIDE; DOXYCYCLINE; GABAPENTIN ; GLIPIDIZE ; LEVOFLOXACIN ; METFORMIN ; TRAVAPROST; VITAMIN B12
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age60 YR
Patient Weight91
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