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

Model Number NA-H21B

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Customer complaint (recalled product): stated device is overheating.

• 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: 16427672
• MDR Text Key: 310066763
• Report Number: 3016774562-2023-00602
• 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
• Report Date: 02/22/2023,02/23/2023

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 Model Number: NA-H21B
• Distributor Facility Aware Date: 01/31/2023
• Date Report to Manufacturer: 02/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1