MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-27 for ALGER BRUSH ALGERBRUSH 2 * manufactured by Alger Company.
[1574373]
A patient arrived complaining of possible particulate in his eye. The doctor performed a slit lamp exam and located a rust ring on the patient's eye. The alger ii device was brought to brush away the rust ring. As the doctor started to brush the eye it was noted that the brush was wobbling and that unstained tissue might be damaged if he continued treatment. The procedure was stopped and the patient was referred to an ophthalmologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1804441 |
| MDR Report Key | 1804441 |
| Date Received | 2010-07-27 |
| Date of Report | 2010-07-22 |
| Date of Event | 2010-07-16 |
| Report Date | 2010-07-22 |
| Date Reported to FDA | 2010-07-27 |
| Date Added to Maude | 2010-08-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALGER BRUSH |
| Generic Name | EYE BURR |
| Product Code | HNA |
| Date Received | 2010-07-27 |
| Model Number | ALGERBRUSH 2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALGER COMPANY |
| Manufacturer Address | 320 FLIGHTLINE RD. LAGO VISTA TX 78645 US 78645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-27 |