MAUDE Adverse Event Report: VITAL FLEX CORE / NINGGUO XIAOXIAO E-COMMERCE CO., LTD. VITAL FLEX CORE; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number 301/501/601

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Superficial (First Degree) Burn (2685)

Event Date 12/02/2023

Event Type  Injury  

Event Description

Received vital flex core marketed as an abdominal muscle toner ab muscles were not stimulated.Instead received painful shocks/burns that did not reach the muscle.

• Brand Name: VITAL FLEX CORE
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): VITAL FLEX CORE / NINGGUO XIAOXIAO E-COMMERCE CO., LTD.
• MDR Report Key: 18291145
• MDR Text Key: 330221182
• Report Number: MW5149017
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/05/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 301/501/601
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Patient Sequence Number: 1
• Patient Sex: Female