MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-03 for UNK * manufactured by Unk.
[244429]
Pt suffering adverse reaction to use of an "activator gun" applied to base of skull during course of treatment by chiropractor. Suffering from a very high-pitched noise which began in 2001, after approximately 1 1/2 mos of treatment 3x/wk. Also what sounds like bone movement can be heard as well. Activator gun. Treatment began in 2000 and continued into 2001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022569 |
| MDR Report Key | 345764 |
| Date Received | 2001-08-03 |
| Date of Report | 2001-08-03 |
| Date of Event | 2001-01-22 |
| Date Added to Maude | 2001-08-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | ACTIVATOR GUN |
| Product Code | GZC |
| Date Received | 2001-08-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 335099 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2001-08-03 |