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

Model Number	SP-6HJA-2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
We received the feedback from importer on (b)(6) 2023 about the event said that one consumer alleged that the massager overheated and burned the skin off her back and scalp and burned out her hair.
Additional Manufacturer Narrative
1.The end user has not returned the product for evaluation and a review of production records for that lot of devices did not show.Any abnormal heating temperature issues.2.Ifu states, ' not to use for more than 15 minutes at a time.' and there is a yellow caution label on the device that states,' never use while sleeping'.3.The failure could not be replicated on sample devices from inventory.

• Brand Name: HOMEDICS
• Common Device Name: SHIATSU BODY MASSAGER WITH HEAT
• Manufacturer (Section D): SMART HOME BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL; 1f-5f, building5#, no.228; jiaosong road; zhangzhou, fujian ; CH
• Manufacturer (Section G): SMART HOME BRANCH OF ZHANGZHOU EASEPAL INDUSTRIAL; 1f-5f, building5#, no.228; jiaosong road; zhangzhou, fujian 36310 7; CH 363107
• Manufacturer Contact: lianzi zhou ; 1f-5f, building5#, no.228; jiaosong road; zhangzhou, fujian 36310-7 ; CH 363107
• MDR Report Key: 16740002
• Report Number: 3015968545-2023-00002
• Device Sequence Number: 6542296
• Product Code: ISA
• UDI-Device Identifier: 00031262107145
• UDI-Public: 031262107145
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: Lay User/Patient
• Device Model Number: SP-6HJA-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown