MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-22 for OAKLEY BRAND SUNGLASSES VALVE manufactured by Oakley.
[5921871]
Since new, anytime i wear these sunglasses, they fog up quickly and without notice. At first, i was not terribly concerned. However, today while driving my car at app 55 mph, the sunglasses suddenly fogged and completely obscured my field of vision. This easily could have caused an accident. I was traveling in the vehicle for nearly an hour when this happened with the windows up and the air conditioning on the low setting. There were no sudden temperature or humidity changes. I sent an email to the manufacturer via their website. Purchase date: (b)(6) 2015. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042848 |
| MDR Report Key | 4802297 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-05-08 |
| Date Added to Maude | 2015-05-29 |
| 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 | 0 |
| 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 |
| Brand Name | OAKLEY BRAND SUNGLASSES |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 2015-05-22 |
| Model Number | VALVE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OAKLEY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |