MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-26 for ADVANTICA EYEGLASS FRAMES manufactured by Advantica.
[2746735]
Plastic nose bridge on prescription glasses is growing fungus/algae and exhibiting greenish corrosion. Possible risk to eyesight. Bridge replaced at 3 months, new one is equally defective. Vendor replaced original part after 4 months ((b)(6)), replacement part is just as bad as original.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025202 |
| MDR Report Key | 2554585 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-04-19 |
| Date of Event | 2011-10-01 |
| Date Added to Maude | 2012-05-02 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTICA EYEGLASS FRAMES |
| Generic Name | EYEGLASS FRAMES |
| Product Code | HQZ |
| Date Received | 2012-04-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANTICA |
| Manufacturer Address | CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-26 |