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 No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Customer complaint limited information available: stated device overheated.Received device as a gift.Does not have an amazon order number.

• 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: 16616849
• MDR Text Key: 312007687
• Report Number: 3016774562-2023-00739
• 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: 03/26/2023

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
• Device Lot Number: 210306
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2023
• Distributor Facility Aware Date: 03/01/2023
• Date Report to Manufacturer: 03/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2023
• Patient Sequence Number: 1