MAUDE Adverse Event Report: SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD. RONDEX; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number B0CCRLRCXS

Patient Problems Pain (1994); Electric Shock (2554); Unspecified Heart Problem (4454)

Event Type  Other  

Event Description

I found that during use this product made me feel very painful.The current of ems is not something that humans can bear.I have a underlying heart condition, and the intensity of this current put me in the hospital.I learned that this type of product is listed on amazon.It needs to be audited by the fda.I would like to know whether the fda has actually audited the seller's information? based on our trust in the fda, i am sending this email for confirmation.I hope the fda can seriously review every seller.This is the protection of our consumers.In addition, it is unreasonable for this product to have so many reviews in a short period of time, which can prove that it deceives consumers through illegal behaviors.As a merchant who often deceives buyers, i have reason to suspect that he uses illegal channels to avoid fda review.

• Brand Name: RONDEX
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): SHENZHEN LIU JIA YI TECHNOLOGY CO.,LTD.
• MDR Report Key: 18311862
• MDR Text Key: 330354214
• Report Number: MW5149131
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: B0CCRLRCXS
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Patient Sequence Number: 1