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

Model Number NA-H21C

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Customer complaint - limited data available customer stated that the device shortened out and produced smoke.A large spark caused the customer to be burned.

Event Description

Customer complaint - limited data available.Customer complained of device shorted out and produced smoke and a large spark, causing customer to be burned.

• 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: 16848543
• MDR Text Key: 314354098
• Report Number: 3016774562-2023-00096
• 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-H21C
• 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: 06/05/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 01/11/2023
• Patient Sequence Number: 1
• Patient Sex: Female