MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-12-21 for * manufactured by Ortho-clinical Diagnostics, Inc..
[21992499]
The instrument has een investigated with the customer over the phone. Customer reports all their hand held barcode scanners are reading an a or b in place of the number 4 problem is intermittent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250051-2004-00515 |
| MDR Report Key | 959380 |
| Report Source | 05,06 |
| Date Received | 2004-12-21 |
| Date Mfgr Received | 2004-11-22 |
| Date Added to Maude | 2007-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA VALLUCCI, PHD |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08669 |
| Manufacturer Country | US |
| Manufacturer Postal | 08669 |
| Manufacturer Phone | 9082188532 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | LRH |
| Date Received | 2004-12-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 929624 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | ROUTE 202 RARITAN NJ 08869 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-21 |