MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-19 for UNK NI manufactured by Unk.
[75459]
According to the rptr, a chiropractor is using an ozone generator to "treat" pts. The chiropractor is reportedly focusing on people with aids and cancer. The rptr became concerned about this practice after seeing a segment on "20/20" about the devices. The rptr is concerned that the treatments may in some way be detrimental and that the devices are not fda approved. The chiropractor has their own web page where they discuss the use of ozone generators.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012480 |
| MDR Report Key | 133310 |
| Date Received | 1997-11-19 |
| Date of Report | 1997-11-19 |
| Date Added to Maude | 1997-11-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | OZONE GENERATOR |
| Product Code | FRA |
| Date Received | 1997-11-19 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 130297 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-19 |