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

Catalog Number B07G2M1LBW

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  Injury  

Event Description

Customer complaint (recalled product): burning hot or barely warm - don't buy this heating pad! ---- terrible and defective.It's either so hot it will burn you or barely warm.The heat is not consistent.It gets extremely hot, hot enough to burn you for several minutes when you turn it on.Then it cools off and barely gets warm.There's no in between.

• 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: 16472982
• MDR Text Key: 310560855
• Report Number: 3016774562-2023-00375
• 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: 01/19/2023,03/02/2023

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 Catalogue Number: B07G2M1LBW
• Date Report to Manufacturer: 01/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1