MAUDE Adverse Event Report: ADVANCE - ESTHETIC LLC CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITS; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number HTTP://ADVANCE-ESTHETIC.US/CAV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 04/01/2019

Event Type  malfunction  

Event Description

Had a treatment with the rf cavitation tens powered stimulators machines and was burned.All these machines require fda 510k clearance and they import from (b)(4) and do not have any fda 510k approvals.Please shut this company down: establishment: (b)(6), (b)(4), status: active, date of registration status: 2019; owner/operator: (b)(6), owner/operator number: (b)(4), official correspondent: (b)(6), phone: (b)(6).(b)(6).Fda safety report id# (b)(4).

• Brand Name: CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITS
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): ADVANCE - ESTHETIC LLC
• MDR Report Key: 8500051
• MDR Text Key: 141743521
• Report Number: MW5085721
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• 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: 04/06/2019

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?: Yes
• Device Operator: Other
• Device Model Number: HTTP://ADVANCE-ESTHETIC.US/CAV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 90