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 Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/12/2022

Event Type  Injury  

Event 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
• 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: 16288102
• MDR Text Key: 308706000
• Report Number: 1832894-2023-00001
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 02/03/2023
• Distributor Facility Aware Date: 12/29/2022
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American