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

Model Number MIGHTY BLISS 201

Device Problem Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Customer complaint - limited data available.The customer was sent a replacement massager but it was faulty.The device gets really hot and had started to melt.

Event Description

Customer complaint - limited data available."customer complaint: hi i know you guys just sent a replacement massager to me but that one is faulty as it gets really hot and was starting to melt.".

• Brand Name: MIGHTY BLISS
• Type of Device: ELECTRIC MASSAGER
• 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: 17342473
• MDR Text Key: 319300900
• Report Number: 3016774562-2023-01634
• Device Sequence Number: 1
• Product Code: ISA
• 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
• Report Date: 07/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MIGHTY BLISS 201
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2023
• Distributor Facility Aware Date: 06/28/2023
• Date Report to Manufacturer: 07/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2024
• Patient Sequence Number: 1