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 Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer allegation: "said she got 2nd degree burns.Said skin peeled off her back.It burned through her clothes.Had black burns.Calling to inform and make us aware.Said purchased on the 12th and woke up on 13th with burns.Offered label to return it for testing.Consumer said she isnt sure.Said maybe she should contact an attorney.Said this isextremely upsetting.Has caused a lot of pain.A lot of suffering.".

• 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: 16288102
• Report Number: 1832894-2023-00001
• Device Sequence Number: 17855558
• Product Code: ISA
• UDI-Device Identifier: 00031262107145
• UDI-Public: 031262107145
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/03/2023
• Report Date (Section F): 02/03/2023

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-6HJ-2
• Device Catalogue Number: SP-6HJ-2
• Device Lot Number: 2022-07-15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/29/2022
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2023
• 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 Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 02/03/2023