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

Model Number SP-6HJA-2

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/12/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 312435948
• Report Number: 3015968545-2023-00001
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SP-6HJA-2
• Device Lot Number: 2022-07-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female