MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-07 for DADE (R) COLAGEN/EPINEPHREINE (COL/EPI) TES CRTG B4170-20 manufactured by Dade Behring Gmbh.
[428469]
A closure time of 113 seconds was obtained for a pt when testedusing dade pfa collagen/epinephrine test cartridge. Pt bled during surgery and pt was given 6 units of packed cells. No other issues regarding pt recovery reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00031 |
| MDR Report Key | 645098 |
| Report Source | 05 |
| Date Received | 2005-11-07 |
| Date of Report | 2005-06-14 |
| Date of Event | 2005-06-14 |
| Date Mfgr Received | 2005-06-14 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2005-11-10 |
| 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 | 0 |
| Manufacturer Contact | STANLEY GORAK |
| Manufacturer Street | P.O. BOX 6101 M/S 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026317458 |
| Manufacturer G1 | DADE MARBURG GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DADE (R) COLAGEN/EPINEPHREINE (COL/EPI) TES CRTG |
| Generic Name | REAGENT, PLATELET AGGREGATION |
| Product Code | GHR |
| Date Received | 2005-11-07 |
| Model Number | NA |
| Catalog Number | B4170-20 |
| Lot Number | 579543 |
| ID Number | NA |
| Device Expiration Date | 2006-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 634586 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * * GM |
| Baseline Brand Name | DADE (R) COLAGEN/EPINEPHREINE (COL/EPI) TEST CRTG |
| Baseline Generic Name | REAGENT, PLATELET AGGREGATION |
| Baseline Model No | NA |
| Baseline Catalog No | B4170-20 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2005-11-07 |