MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-18 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Hamitlon Bonaduz Ag.
[19054585]
The ortho summit processor is reportedly generating low assay results; od readings less than zero. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2004-02728 |
| MDR Report Key | 968786 |
| Date Received | 2004-08-18 |
| Date of Report | 2004-08-18 |
| Date of Event | 2004-07-23 |
| Date Added to Maude | 2007-12-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | ORTHO SUMMIT PROCESSOR |
| Generic Name | ELISA MICROWELL PLATE PROCESSOR |
| Product Code | JTL |
| Date Received | 2004-08-18 |
| Model Number | 7003015 |
| Catalog Number | 936480 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 938216 |
| Manufacturer | HAMITLON BONADUZ AG |
| Manufacturer Address | * BONADUZ * SZ CH 7402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-18 |