MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-06-16 for IMX B12 CALIBRATOR 2200-01 manufactured by Abbott Health Products, Inc..
[22184074]
On 5/17/97, the operator was setting up b-12 assay and while trying to determine the amount of calibrator a (lot number 22312q100) in the bottle, accidently squeezed the bottle and sprayed her face and one eye. She thought she got some in her rt eye. She rinsed her eye thoroughly at the emergency eye wash station in the lab. She stated she had not noticed any adverse reactions. The imx operator stated the emergency room flushed her eye again with 500 cc water. She had no adverse effects from the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-1997-00016 |
| MDR Report Key | 99019 |
| Report Source | 06 |
| Date Received | 1997-06-16 |
| Date of Report | 1997-06-13 |
| Date of Event | 1997-05-17 |
| Date Mfgr Received | 1997-05-17 |
| Device Manufacturer Date | 1996-10-01 |
| Date Added to Maude | 1997-06-20 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX B12 CALIBRATOR |
| Generic Name | IMX B12 CALIBRATOR |
| Product Code | JIS |
| Date Received | 1997-06-16 |
| Model Number | NA |
| Catalog Number | 2200-01 |
| Lot Number | 22312Q100 |
| ID Number | NA |
| Device Expiration Date | 1997-05-18 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 97585 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-16 |