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	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
We received the feedback from importer on 03-feb-2023 about the event said that one consumer alleged they got 2nd degree burns with skin peeled off her back.The end user alleged they purchased our product on the 12-dec-2022 and woke up on (b)(6) 2022 with the burns.
Additional Manufacturer Narrative
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.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'.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; 1/f-5/f, building 5#, no.228; jiaosong road; zhangzhou, fujian 36310 0; CH 363100
• Manufacturer (Section G): ZHANGZHOU EASEPAL INDUSTRIAL; 1f-5f, building 5#, no. 228; jiaosong road; zhangzhou, fujian 36310 7; CH 363107
• Manufacturer Contact: lian zhou ; 1f-5f, building 5#, no. 228; jiaosong road; zhangzhou, fujian 36310-7 ; CH 363107
• MDR Report Key: 16655810
• Report Number: 3015968545-2023-00001
• Device Sequence Number: 5924659
• 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): 03/31/2023

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
• Device Lot Number: 2022-07-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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 Age: 54 YR
• Patient Sex: Female