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

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 01/27/2022

Event Type  Injury  

Event Description

Customer complaint: (recalled product): first ordered for my elderly dad, a few months ago he said he burnt his leg.The pad had burn holes in the material.Could have caused a fire.

• 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: 16453056
• MDR Text Key: 310351195
• Report Number: 3016774562-2023-00573
• 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: 02/22/2023,02/28/2023

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
• Date Report to Manufacturer: 02/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1