MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-05-16 for * manufactured by Ortho-clinical Diagnostics, Inc..
| Report Number | 2250051-2002-00069 |
| MDR Report Key | 395859 |
| Report Source | 05 |
| Date Received | 2002-05-16 |
| Date of Event | 2002-03-28 |
| Date Mfgr Received | 2002-05-14 |
| Date Added to Maude | 2002-05-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JUDY STRZEPEK |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 088690606 |
| Manufacturer Country | US |
| Manufacturer Postal | 088690606 |
| Manufacturer Phone | 9087048524 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | JTL |
| Date Received | 2002-05-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Age | YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 384866 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| 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 | 2002-05-16 |