MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-25 for BRUNO REGAL SCOOTER UNK manufactured by Bruno Co.
[20143179]
The scooter and the lift are not compatible. The weld, wheels, and bolts have broken off four times. User has complained to the mfr but has not received any assistance from them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019785 |
| MDR Report Key | 292810 |
| Date Received | 2000-08-25 |
| Date of Report | 2000-08-25 |
| Date of Event | 1999-01-01 |
| Date Added to Maude | 2000-08-30 |
| 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 | BRUNO REGAL SCOOTER |
| Generic Name | SCOOTER |
| Product Code | INI |
| Date Received | 2000-08-25 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 283411 |
| Manufacturer | BRUNO CO |
| Manufacturer Address | * * WI * US |
| Brand Name | BRUNO LIFT |
| Generic Name | LIFT |
| Product Code | ILK |
| Date Received | 2000-08-25 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 283413 |
| Manufacturer | BRUNO CO. |
| Manufacturer Address | * * WI * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-25 |