MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-10-05 for LIQUICHEK CARDIAC MARKERS CONTROL LT 647 manufactured by Bio-rad Laboratories.
[15449206]
A lab professional splashed level 2, cardiac markers lt in their eye. The event occurred in 2004 while the customer was working at their part-time job.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2004-00002 |
| MDR Report Key | 547225 |
| Report Source | 05,07 |
| Date Received | 2004-10-05 |
| Date of Report | 2004-09-24 |
| Date of Event | 2004-08-28 |
| Date Mfgr Received | 2004-09-02 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2004-10-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LOURDES BERNAL, REP |
| Manufacturer Street | 9500 JERONIMO RD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981338 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK CARDIAC MARKERS CONTROL LT |
| Generic Name | ENZYME CONTROLS (ASSAYED AND UNASSAYED) |
| Product Code | JJT |
| Date Received | 2004-10-05 |
| Model Number | NA |
| Catalog Number | 647 |
| Lot Number | 31132 |
| ID Number | NA |
| Device Expiration Date | 2005-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 536633 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US |
| Baseline Brand Name | LIQUICHEK CARDIAC MARKERS CONTROL LT |
| Baseline Generic Name | ENZYME CONTROLS (ASSAYED AND UNASSAYED) |
| Baseline Model No | NA |
| Baseline Catalog No | 647 |
| Baseline ID | NA |
| Baseline Device Family | CONTROLS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K021498 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-05 |