MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-19 for STA COAG CONTROL N 00676 manufactured by Diagnostica Stago.
[768275]
One injury occurred (a deep cut to the thumb) on a laboratory technician while trying to open control vial. The entire top broke off and the jagged edge of the remaining bottle cut through the gloves into her thumb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245451-2006-00001 |
| MDR Report Key | 966370 |
| Date Received | 2006-05-19 |
| Date of Report | 2006-05-15 |
| Date of Event | 2005-12-06 |
| Date Facility Aware | 2005-12-06 |
| Report Date | 2006-05-15 |
| Date Added to Maude | 2007-12-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA COAG CONTROL N |
| Generic Name | NORMAL QUALITY CONTROL PLASMA |
| Product Code | JTL |
| Date Received | 2006-05-19 |
| Model Number | NA |
| Catalog Number | 00676 |
| Lot Number | 042736 |
| ID Number | NA |
| Device Expiration Date | 2006-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 935931 |
| Manufacturer | DIAGNOSTICA STAGO |
| Manufacturer Address | * TAVERNY FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-19 |