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

Model Number SP-6HJ-2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Hair Loss (1877)

Event Date 01/30/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 309899553
• Report Number: 1832894-2023-00003
• Device Sequence Number: 1
• Product Code: ISA
• UDI-Device Identifier: 00031262107145
• UDI-Public: 031262107145
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023,02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 02/22/2023
• Distributor Facility Aware Date: 02/10/2023
• Device Age: 17 MO
• Event Location: Home
• Date Report to Manufacturer: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other