MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-25 for GLAUCOMA LASER SCAN manufactured by .
[16642913]
Pt was put on the laser scan and developed the following symptoms! Burned eyes, blue circle and blisters on both eyes, she initially got cloudy vision and is now having pain and pressure on her eyes, and her eyes are irritated. Pt stated that the reason she initially went to doctor was high blood pressure, but they put her on this scan equipment. Pt had no device id info available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008396 |
| MDR Report Key | 1174063 |
| Date Received | 2008-09-25 |
| Date of Report | 2008-09-25 |
| Date Added to Maude | 2008-09-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GLAUCOMA LASER SCAN |
| Product Code | HKX |
| Date Received | 2008-09-25 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1206700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-25 |