FDA Adverse Event
Injury
Summary report: N
RAYBAN EYEGLASSES MODEL RB8903 5263 SIZE 55
MDR report key: 21264816
·
Received January 29, 2025
Report
- Report Number
- MW5165400
- Event Type
- Injury
- Date Received
- January 29, 2025
- Report Date
- January 23, 2025
- Manufacturer
- MORPHEUS ADVISOR SRL
- Product Code
- HQG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
I HAD A REACTION FROM A PAIR OF EYEGLASSES' TEMPLE PADS THAT I HAD WORN FOR SEVERAL YEARS. BEGINNING IN (B)(6) 2024 I STARTED DEVELOPING FLAKY SKIN, A STICKY DISCHARGE AND ITCHING THAT CONTINUED UNTIL I GOT A NEW PAIR OF GLASSES (B)(6) 2025. THE SYMPTOMS INSTANTLY RESOLVED AND I TRIED THE OLD GLASSES FOR A DAY AND THE SYMPTOMS IMMEDIATELY RETURNED. I CALLED (B)(6) TO REPORT INCIDENT TO THEM AND THEY SAID THEY COULDN'T TAKE THE INFORMATION. THE GLASSES WERE (B)(6) MODEL RB 8903 5263 SIZE 55.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 843016 | RAYBAN EYEGLASSES MODEL RB8903 5263 SIZE 55 | LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | HQG | MORPHEUS ADVISOR SRL | RB8903 5263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | LOSARTAN.| MONTELUKAST.| TADALAFIL.| XYZAL. |