MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for OPTOMAP RETINAL SCREENING manufactured by Unk.
[184153121]
Reporter stated that she had a screening done on a optomap retinal screening machine at the optometrist office on (b)(6) 2020. She woke up the next morning with a slight headache, blurred vision on her right eye and both eyes were red and she felt a little dizzy. She also stated that this symptoms lasted all day. Pt applied an eye drop to her eyes which helped a little. She believe this reaction is as a result of the screening machine. Pt tried to reach the dr's office to inform him about her symptoms but the dr was not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093745 |
| MDR Report Key | 9829317 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-02 |
| Date Added to Maude | 2020-03-13 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTOMAP RETINAL SCREENING |
| Generic Name | DEVICE, COMMUNICATIONS, IMAGES, OPHTHALMIC |
| Product Code | NFG |
| Date Received | 2020-03-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |