MAUDE Adverse Event Report: SMART HOME BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL HOMEDICS; SHIATSU BODY MASSAGER WITH HEAT

Model Number	SP-6HJ-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Hair Loss (1877)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user claimed the following: "i wanted to report how dissatisfied with your homedics neck and back heated massager from walmart.The massager overheated and burned the skin off my back and scalp and burned out my hair.I have plenty of pictures and proof of injury and how your product caused it.I have retained a lawyer and will be filing a lawsuit for my pain and suffered.Product defect.Personal injury with 98% chance of winning.I'm very disappointed but not angry.Just emotional.I had been growing my hair for years.".

• Brand Name: HOMEDICS
• Common Device Name: SHIATSU BODY MASSAGER WITH HEAT
• Manufacturer (Section D): SMART HOME BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL; 1/f-5/f.building5#,no.228 jiao; taiwanese investment zone; zhangzhou, fujian 36310 0; CH 363100
• MDR Report Key: 16410248
• Report Number: 1832894-2023-00003
• Device Sequence Number: 3504261
• Product Code: ISA
• UDI-Device Identifier: 00031262107145
• UDI-Public: 031262107145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/22/2023

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?: No
• Operator of Device: Other
• Device Model Number: SP-6HJ-2
• Device Catalogue Number: SP-6HJ-2
• Device Lot Number: 08/21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2023
• Device Age: 17 MO
• Event Location: Home
• Date Report to Manufacturer: 02/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/22/2023