MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-10 for GOLDMAN APPLANATION TONOMETER UNK manufactured by Unk.
[376071]
Technician was doing a glaucoma test on pt in clinic. The pt experienced pain in the rt eye due to the device. The pt has had impaired vision after the event. The rt eye hurts. The eye dr and technician denied that there was any problem with the device or the operation of the device. Pt visited another physician, who certified that the cornea was damaged due to the device. This physician has recommended corneal transplant to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034067 |
| MDR Report Key | 563514 |
| Date Received | 2004-11-10 |
| Date of Report | 2004-11-10 |
| Date of Event | 2004-06-01 |
| Date Added to Maude | 2005-01-07 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDMAN APPLANATION TONOMETER |
| Generic Name | USED TO MEASURE GLAUCOMA |
| Product Code | HKX |
| Date Received | 2004-11-10 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 553243 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2004-11-10 |