FDA Adverse Event
Malfunction
Summary report: N
KATE SPADE BRYLIE RNL 135
MDR report key: 18990006
·
Received March 27, 2024
Report
- Report Number
- MW5153284
- Event Type
- Malfunction
- Date Received
- March 27, 2024
- Date of Event
- February 26, 2024
- Report Date
- March 25, 2024
- Manufacturer
- COACH SERVICES INC. DBA KATE SPADE C/O SOLUCIONES XB MEXICO, S. DE R.L. DE C.V.
- Product Code
- HOI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE FRAME OF MY EYEGLASSES BROKE NEAR WHERE THE RIGHT ARM JOINS THE FRONT FRAME AFTER LESS THAN 1 YEAR OF HAVING THEM. I HAVE THE SAME GLASSES FROM AN EARLIER / SLIGHTLY DIFFERENT PRESCRIPTION AND I USED THOSE AS A BACKUP. THEN THEY BROKE IN THE EXACT SAME PLACE. I THINK THE DESIGN IS FLAWED. I CAN'T SEE WITHOUT MY GLASSES, SO I HAD TO ORDER A NEW FRAME. THE FRAME MY NEWER GLASSES IS KATE SPADE BRYLEI RNL 135 AND THE OLDER IS KATE SPADE BRYLIE OTQ 135. REFERENCE REPORT #MW5153285.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1913662 | KATE SPADE BRYLIE RNL 135 | SPECTACLE, MAGNIFYING | HOI | COACH SERVICES INC. DBA KATE SPADE C/O SOLUCIONES XB MEXICO, S. DE R.L. DE C.V. | BRYLIE RNL 135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | CALCIUM + D.| FLAXSEED OIL.| MULTIVITE.| VITAMIN D. |