MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-06-24 for VITROS CALIBRATOR KIT 2 1662659 manufactured by Ortho-clinical Diagnostics, Inc..
[20763681]
A laboratory technologist was splashed in the eyes upon opening diluent bottle four of calibrator kit 2. Per msds and labeling for vitros clinical chemistry calibrator kit 2 - calibrator level 4; this fluid is an eye irritant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2003-00136 |
| MDR Report Key | 467798 |
| Report Source | 05 |
| Date Received | 2003-06-24 |
| Date of Report | 2003-06-03 |
| Date of Event | 2003-06-03 |
| Date Mfgr Received | 2003-06-03 |
| Device Manufacturer Date | 2002-10-01 |
| Date Added to Maude | 2003-06-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CYNTHIA PETERS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854533807 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITROS CALIBRATOR KIT 2 |
| Generic Name | IN VITRO CALIBRATOR |
| Product Code | LBR |
| Date Received | 2003-06-24 |
| Model Number | NA |
| Catalog Number | 1662659 |
| Lot Number | 223 |
| ID Number | NA |
| Device Expiration Date | 2005-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 456725 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 146265101 US |
| Baseline Brand Name | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
| Baseline Generic Name | CALIBRATOR KIT 2 |
| Baseline Model No | NA |
| Baseline Catalog No | 1662659 |
| Baseline ID | NA |
| Baseline Device Family | VITROS CALIBRATOR KIT |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 27 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K012593 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-06-24 |