FDA Adverse Event
Other
Summary report: N
CONVERSE EYEGLASSES
MDR report key: 3667625
·
Received March 4, 2014
Report
- Report Number
- MW5034822
- Event Type
- Other
- Date Received
- March 4, 2014
- Date of Event
- February 20, 2014
- Report Date
- February 24, 2014
- Product Code
- HQZ
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
MY SON HAS A PAIR OF PRESCRIPTION (B)(6) EYEGLASSES, MODEL WHY 49-15-130. HE AND A FRIEND WERE PLAYING ON THE PLAYGROUND AND HIS GLASSES BROKE ON THE FRONT EDGE OF THE FRAME AND CREATED A SHARP, KNIFELIKE EDGE. THE FRAME ITSELF BROKE, NOT AT THE HINGE. THE LENS DID NOT BREAK. THIS SHARP EDGE CUT HIM ON HIS EYEBROW. IT WAS ABOUT AN INCH AND A HALF LACERATION AND REQUIRED EIGHT STITCHES. I AM REPORTING THIS BECAUSE I FEEL IT IS A SAFETY ISSUE WHICH COULD HAVE RESULTED IN A MUCH MORE SERIOUS INJURY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129913 | CONVERSE EYEGLASSES | CONVERSE BOYS EYEGLASSES BLACK AND WHITE | HQZ | WHY 49-15-130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |