MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-26 for LA1 SCREENING REAGENT/LA2 CONFIRMATION REAGENT OQGR-11 manufactured by Dade Behring Gmbh.
[427305]
Laboratorian received a laceration while attempting to open a vial of la2 reagent. The vial broke as the laboratorian was removing the cap from the vial. Laboratorian received medical treatment for the laceration, plastic stitches and a tetanus shot at the emergency room. Upon inspection, the laboratorian noticed shards of glass in the bottom of the shipping container. The vial breakage most likely occurred during transit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2005-00015 |
| MDR Report Key | 627959 |
| Report Source | 05 |
| Date Received | 2005-07-26 |
| Date of Report | 2005-07-19 |
| Date of Event | 2005-06-22 |
| Date Mfgr Received | 2005-06-27 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2005-08-19 |
| 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 | VICTOR CARRIO |
| Manufacturer Street | P.O. BOX 6101, MS 514 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | * |
| Manufacturer G1 | DADE BEHRING 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LA1 SCREENING REAGENT/LA2 CONFIRMATION REAGENT |
| Generic Name | SIMPLIFIED DILUTE RUSSELL'S VIPER VENOM TEST |
| Product Code | GIR |
| Date Received | 2005-07-26 |
| Model Number | NA |
| Catalog Number | OQGR-11 |
| Lot Number | 524209 |
| ID Number | NA |
| Device Expiration Date | 2005-07-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 617591 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | LA2 CONFIRMATION REAGENT |
| Baseline Generic Name | DETERMINATION OF LUPUS ANTICOAGULANTS |
| Baseline Model No | NA |
| Baseline Catalog No | OQGR-11 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K922156 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-26 |