MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-03 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Hamilton Bonaduz Ag.
[372738]
User error. The customer used the wrong correction factor when performing dispenser verifications on the ortho summit processor. No death or serious injury was assoicated with the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2004-02604 |
| MDR Report Key | 584787 |
| Date Received | 2004-06-03 |
| Date of Report | 2004-06-03 |
| Date of Event | 2004-05-04 |
| Date Added to Maude | 2005-03-28 |
| 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 | 2004-06-03 |
| 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 | 574615 |
| Manufacturer | HAMILTON BONADUZ AG |
| Manufacturer Address | * BONADUZ SZ CH 7402 |
| Baseline Brand Name | ORTHO SUMMIT PROCESSOR |
| Baseline Generic Name | SAMPLE PROCESSOR |
| Baseline Model No | 7003015 |
| Baseline Catalog No | 936480 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-03 |