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

Model Number NA-H1121B

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Customer complaint - limited data available.Customer complained that their heating pad was not working correctly.They alluded to an injury on their lower back but that was not confirmed.

Event Description

Customer complaint - limited data available.Per public email folder: " i do have a area on my back, i suppose the heating pad may have caused.I have pictures of the heating pad with cord cut and picture of my lower back area attached" customer did not provide amazon order number or address.Will update ae form once return call, replied back to email with requested information.Email.Did not mention if sought medical attention or expectation.

Event Description

Customer complaint - limited data available per public email folder: " i do have an area on my back, i suppose the heating pad may have caused.I have pictures of the heating pad with cord cut and picture of my lower back area attached" customer did not provide amazon order number or address.Will update ae form once return call, replied back to email with requested information.Email xxxxxxxx@gmail.Com.Did not mention if sought medical attention or expectation.

• 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: 16888881
• MDR Text Key: 314767185
• Report Number: 3016774562-2023-00338
• 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,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NA-H1121B
• Device Lot Number: 211203
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2023
• Distributor Facility Aware Date: 11/22/2022
• Device Age: 2 YR
• Date Report to Manufacturer: 01/11/2023
• Patient Sequence Number: 1