MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-05 for ZERONA manufactured by Erchonia Corporation.
[182738699]
Cancer; i received zerona therapy (makes holes in fat cells) in one particular area under my arm pit / near my breast in 2014 and now 6 years later i have breast cancer in that exact same location (i'm (b)(6) y/o) and feel there is a link as i have no family history. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093577 |
| MDR Report Key | 9800735 |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-21 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Brand Name | ZERONA |
| Generic Name | FAT REDUCING LOW LEVEL LASER |
| Product Code | OLI |
| Date Received | 2020-03-05 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERCHONIA CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-05 |