MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITS HTTP://ADVANCE-ESTHETIC.US/CAV manufactured by Advance - Esthetic Llc.
[141743521]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085721 |
| MDR Report Key | 8500051 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-04-06 |
| Date of Event | 2019-04-01 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITS |
| Generic Name | MASSAGER, THERAPEUTIC, ELECTRIC |
| Product Code | ISA |
| Date Received | 2019-04-09 |
| Model Number | HTTP://ADVANCE-ESTHETIC.US/CAV |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCE - ESTHETIC LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-09 |