MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-19 for * manufactured by Diagnostica Stago.
[7928736]
Human plasma is used for the preparation of sta coag control n, cat. 00676, lot # 042736. Fda-approved methods are used to test the human plasma for antibodies to hiv 1, hiv 2, and hcv, and for hepatitis b surface antigen. Only plasmas negative for all markers are used for mfg this prod. The following warning is mentioned in the package insert of this reagent: "the reagents provided in this kit contain materials of human and/or animal origin. Whenever human plasma is required for the preparation of these reagents, fda-approved methods are used to test the plasma for the antibodies to hiv 1, hiv 2, and hcv, and for hepatitis b surface antigen and results are found to be negative. However, no test method can offer complete assurance that infectious agents are absent. Therefore, users of reagents of these types must exercise extreme care in full compliance with regulatory safety precautions in the manipulation of these biological materials as if they were infectious. " it is indicated in the package insert of this reagent section 3/ kit reagents the following : "reagent 1: sta coag control n, citrated normal human plasma, freeze dried. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710666-2006-00001 |
| MDR Report Key | 966446 |
| Report Source | 05 |
| Date Received | 2006-05-19 |
| Date Mfgr Received | 2006-04-12 |
| Device Manufacturer Date | 2004-10-01 |
| Date Added to Maude | 2007-12-19 |
| 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 Street | 9 RUE DES FRERES CHAUSSON |
| Manufacturer City | ASNIERES 92600 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92600 |
| Manufacturer Phone | 3313072362 |
| Manufacturer G1 | DIAGNOSTICA STAGO-TAVERNY SITE |
| Manufacturer Street | 23/29 RUE CONSTANTIN PECQUEUR |
| Manufacturer City | TAVERNY 95150 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95150 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | JTL |
| Date Received | 2006-05-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 935969 |
| Manufacturer | DIAGNOSTICA STAGO |
| Manufacturer Address | 23/29 RUE CONSTANTIN PECQUER TAVERNY FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-19 |