MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-27 for "RIFE MACHINE" * manufactured by *.
[20934148]
Consumer stated that he purchased an electronic machine known by various names which include "engery wellness", "frequency wellness instrument", "rife machine", "rife generator", et al. He bought the machine because it was touted as a cure for hiv-aids; as well as disease. Sales person told him that the machine was a "resonance generator", and it would kill "pathogens and organisms. " he was told that there was a 30 day "free trial. " in reading a pamphlet, the consumer learned later that the machine was not fda approved. He returned the machine and hopes that he will get a full refund.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003986 |
| MDR Report Key | 756346 |
| Date Received | 2005-07-27 |
| Date of Report | 2005-04-28 |
| Date Added to Maude | 2006-09-01 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "RIFE MACHINE" |
| Generic Name | ENERGY WELLNESS |
| Product Code | HCC |
| Date Received | 2005-07-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 744225 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-27 |