MAUDE Adverse Event Report: AB SONIC GEL CONDUCTEUR; MEDIA, ELECTROCONDUCTIVE

Lot Number UG01100120

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Discomfort (2330)

Event Date 09/05/2021

Event Type  Injury  

Event Description

Extremely bad rash; i have a cavitation machine and i use gel for my inner thighs just one time.I still have the bottles if so i can bring to test.The rash spread to my lady parts inner thighs of course and lower belly.I took pictures and im now on antibiotics penicillin and cream.I pray it goes away.Im miserable i never experienced this type of uncomfortableness.Im 99.99% its the cause of my suffering.Sign from god never happened before.I did not test but (b)(6) contacted me, i would have never known.I live in (b)(6) and i can bring the actual bottle i used one time along with un open bottles.Cavitation machine fat cellulite treatment.

• Brand Name: AB SONIC GEL CONDUCTEUR
• Type of Device: MEDIA, ELECTROCONDUCTIVE
• MDR Report Key: 12507179
• MDR Text Key: 272908039
• Report Number: MW5104110
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/10/2023
• Device Lot Number: UG01100120
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 95