MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-23 for ORTHO ANTI-IGG,-C3D; POLYSPECIFIC BIOCLONE GREEN 716980 manufactured by Ortho Clinical Diagnostics.
| Report Number | 2250051-2020-00007 |
| MDR Report Key | 9622902 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-06-26 |
| Date Added to Maude | 2020-01-23 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| Manufacturer Street | 1001 ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082188223 |
| Manufacturer G1 | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Street | 1001 ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO ANTI-IGG,-C3D; POLYSPECIFIC BIOCLONE GREEN |
| Generic Name | ANTI-HUMAN BIOCLONE |
| Product Code | KSZ |
| Date Received | 2020-01-23 |
| Catalog Number | 716980 |
| Lot Number | RMG471D1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Address | 1001 ROUTE 202 RARITAN NJ 08869 US 08869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |