MAUDE Adverse Event Report: XIAMEN HEALTHPAL ELECTRONIC CO,.LTD. MIGHTY BLISS; ELECTRIC MASSAGER

Catalog Number B07GJY3J5B

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Customer complaint:: it'd turn on for few seconds then stop.Light is blinking red and blue.Smells a bit like burning rubber too.I tried re-charging.Tried resetting it per manual.Tried it without any attachment.Still quits after few seconds.

• Brand Name: MIGHTY BLISS
• Type of Device: ELECTRIC MASSAGER
• Manufacturer (Section D): XIAMEN HEALTHPAL ELECTRONIC CO,.LTD.; no.148 binglang xili , siming; no.170 siming park tongan dist; xiamen, fujian 36110 0; CH 361100
• MDR Report Key: 16504174
• MDR Text Key: 310896649
• Report Number: 3016774562-2023-00634
• 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
• Report Date: 03/01/2023,03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: B07GJY3J5B
• Date Report to Manufacturer: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1