MAUDE Adverse Event Report: XI AN BELLAVIE AND SUNBRIGHT GROUP CO.,LTD. MIGHTY BLISS; HEATING PAD

Model Number NA H21BF

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Customer complaint : limited data available.Customer complained that the device was set on low and they fell asleep while using the device.When they awoke their arm was burned due to the heating pad.

Event Description

Customer complaint - limited data available.Customer complained of device was set on low and she fell asleep while using it on her arm.She woke to her arm burning.

• Brand Name: MIGHTY BLISS
• Type of Device: HEATING PAD
• Manufacturer (Section D): XI AN BELLAVIE AND SUNBRIGHT GROUP CO.,LTD.; 4-1101, taihua jinmao; intl plaza, n16th s fenghui rd; xi'an, shaanxi ; CH
• MDR Report Key: 16848152
• MDR Text Key: 314352372
• Report Number: 3016774562-2023-00094
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NA H21BF
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2023
• Distributor Facility Aware Date: 02/26/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 01/11/2023
• Patient Sequence Number: 1