MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-08 for manufactured by .
[19517977]
Ortho-clinical diagnostics (ocd) qa performed retain testing to confirm the reactivity of the e antigens. Satisfactory results were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00483 |
| MDR Report Key | 965127 |
| Report Source | 05,06 |
| Date Received | 2006-11-08 |
| Date Mfgr Received | 2006-10-10 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2007-12-18 |
| 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 VELLUCCI PH.D. |
| Manufacturer Street | 1001 US HWY 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| 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 |
| Product Code | KZS |
| Date Received | 2006-11-08 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 934789 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-08 |