MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for ARMANI EXCHANGE manufactured by Ezcontacts Usa.
[24958224]
Incident description: product - armani exchange ax3012 eyeglasses. (b)(6). Defect of product: frame of eyeglasses distorted, one leg goes up and one leg goes down, 15% degree between two legs, feel dizzy after wearing, damage to eyesight. Explanation: i still have the product. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055809 |
| MDR Report Key | 5038583 |
| Date Received | 2015-08-25 |
| Date of Report | 2015-08-13 |
| Date of Event | 2015-07-31 |
| Date Added to Maude | 2015-08-28 |
| 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 |
| 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 | ARMANI EXCHANGE |
| Generic Name | EYEGLASSES WITH PRESCRIPTIONS |
| Product Code | HQG |
| Date Received | 2015-08-25 |
| Model Number | ARMANI EXCHANGE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EZCONTACTS USA |
| Manufacturer Address | 243 PARK AVE BROOKLYN NY 11205 US 11205 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |