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 01/30/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 313301670
• Report Number: 3015968545-2023-00002
• 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: 03/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: SP-6HJA-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 04/13/2023
• 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