MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-07 for ABBOTT HCV EIA 2.0 4A14-24 manufactured by Abbott Laboratories.
[51428]
On 4/7/97, a technician was splashed in the eye while discarding the contents of a test tube containing co hcv positive control coated bead, 1n sulfuric acid, and o-phenyenediamine in citrate-phosphate buffer. The tube labeled "positive control" slipped out of the technician's hand and bounced off the floor thus splashing the contents of it into her right eye. The eye was flushed with water for 5 minutes. The technician sustained corneal abrasion that was treated with erythromycin. The technician was wearing safety equipment that included glasses, gloves, and a lab coat. On 4/9/97, the technician's eye was examined by an opthalmologist and the abrasion was healed. The account would not furnish the weight of the technician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-1997-00012 |
| MDR Report Key | 89966 |
| Report Source | 05,06 |
| Date Received | 1997-05-07 |
| Date of Report | 1997-05-07 |
| Date of Event | 1997-04-07 |
| Date Mfgr Received | 1997-04-08 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-05-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT HCV EIA 2.0 |
| Generic Name | EIA FOR DETECTION OF HEPATITIS C ANTIBODY |
| Product Code | LQI |
| Date Received | 1997-05-07 |
| Model Number | NA |
| Catalog Number | 4A14-24 |
| Lot Number | 27521M100 |
| ID Number | NA |
| Device Expiration Date | 1997-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 88942 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100/200 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | ABBOTT HCV EIA 2.0 |
| Baseline Generic Name | EIA FOR DETECTION OF HCV ANTIBODY |
| Baseline Model No | NA |
| Baseline Catalog No | 4A14-24 |
| Baseline ID | NA |
| Baseline Device Family | ABBOTT HCV EIA 2.0 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-07 |