MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for PRESCRIPTION GLASSES 5975 CL manufactured by Marchon.
[99293567]
I had an allergic reaction to my new glasses that were prescribed by my optometrist, dr. (b)(6) in (b)(6). Within a day of wearing the glasses, i developed a painful and itchy rash everywhere the frames touched my skin. The frames were calvin klein 5975 cl. Calvin klein 5975.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075076 |
| MDR Report Key | 7244554 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-03 |
| Date Added to Maude | 2018-02-06 |
| 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 | PRESCRIPTION GLASSES |
| Generic Name | PRRECRIPTION GLASSES |
| Product Code | HQG |
| Date Received | 2018-02-05 |
| Model Number | 5975 CL |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARCHON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-02-05 |