MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-14 for HD400 PRESCRIPTION FRAME manufactured by Viva International Group.
[23685739]
While driving, the hinge on my (b)(6) prescription glasses frame failed, causing the glasses to slide off my face. This resulted in a serious hazard as my eyesight without correction is not sufficient for driving a vehicle. I was able to safely stop and switch to my prescription sunglasses, but could easily have been involved in an accident. The hinge of the right earpiece failed, causing the earpiece to detach. The hinge has an over-travel mechanism, and the pivot link appears to be under-designed. There is very little material at crucial points, allowing metal fatigue to cause failure in very few hinge actuation cycles. I have the glasses still, and would be glad to send them for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055602 |
| MDR Report Key | 5018911 |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-08-13 |
| Date Added to Maude | 2015-08-20 |
| 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 | 0 |
| Brand Name | HD400 PRESCRIPTION FRAME |
| Generic Name | HD400 PRESCRIPTION FRAME |
| Product Code | HQG |
| Date Received | 2015-08-14 |
| Model Number | HD400 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIVA INTERNATIONAL GROUP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-08-14 |