MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for SWITCH AVALANCHE manufactured by Switch.
[18027664]
Incident description: frame of sunglasses snapped at the bridge while putting them on and sharp end hit me in the eye causing pain. Product description: the brand is switch. The model is avalanche. They are sports sunglasses with changeable lenses. The lenses are held in by magnets. The frames snapped at the end of one of the embedded magnets. Reminds me of breaking a stick over my knee. May be the magnet took the flexibility out of the frame at the fracture point. (b)(4). Retailer: (b)(6). Retailer state: (b)(6). Purchase date: (b)(6) 2013 this date is an estimate. The product was not damaged before the incident. The product was not modified before the incident. Across 3-4 weeks i sent two emails through (b)(4), but received no reply. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042648 |
| MDR Report Key | 4768841 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-25 |
| Date of Event | 2015-04-05 |
| Date Added to Maude | 2015-05-14 |
| 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 |
| 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 | SWITCH |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 2015-05-08 |
| Model Number | AVALANCHE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SWITCH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-08 |