MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-25 for PEGASYS * manufactured by Adac Laboratories.
[21693132]
Collimator exchange carrier was out of adjustment. Fell on employee causing strain to back and injury to hip and right foot. Field rep notified. On-site visit conducted of equipment. Exchange carriage was out of adjustment. Adjusted carrier and cleaned bearings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029682 |
| MDR Report Key | 489082 |
| Date Received | 2003-09-25 |
| Date of Report | 2003-09-25 |
| Date of Event | 2003-09-19 |
| Date Added to Maude | 2003-10-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PEGASYS |
| Generic Name | COLLIMATOR EXCHANGER CARRIER |
| Product Code | KPW |
| Date Received | 2003-09-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 6886VM GANTRY #9702142 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 477866 |
| Manufacturer | ADAC LABORATORIES |
| Manufacturer Address | 540 ALDER DRIVE MILPITAS CA 95035 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-25 |