MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-05-15 for ANTI-LE (MURINE MONOCLONAL) BIOCLONE NI 103083 manufactured by Ortho-clinical Diagnostics.
[304788]
Customer reported that negative reactions were observed with this product and lea+ cells. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2250051-2003-00112 |
| MDR Report Key | 461451 |
| Report Source | 05 |
| Date Received | 2003-05-15 |
| Date of Report | 2003-05-12 |
| Date of Event | 2003-04-23 |
| Date Mfgr Received | 2003-04-23 |
| Date Added to Maude | 2003-05-23 |
| 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 | NANCY PAPCIAK |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 088690606 |
| Manufacturer Country | US |
| Manufacturer Postal | 088690606 |
| Manufacturer Phone | 9087043872 |
| 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 | ANTI-LE (MURINE MONOCLONAL) BIOCLONE |
| Generic Name | BLOOD GROUPING REAGENT |
| Product Code | GNY |
| Date Received | 2003-05-15 |
| Model Number | NI |
| Catalog Number | 103083 |
| Lot Number | LAB112A |
| ID Number | NA |
| Device Expiration Date | 2003-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 450393 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 US HWY 202 RARITAN NJ 088690606 US |
| Baseline Brand Name | ANTI-LE (MURINE MONOCLONAL) BIOCLONE |
| Baseline Generic Name | BLOOD GROUPING REAGENT |
| Baseline Model No | NI |
| Baseline Catalog No | 103083 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-05-15 |