MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-04 for CONVERSE EYEGLASSES WHY 49-15-130 manufactured by .
[4344457]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034822 |
| MDR Report Key | 3667625 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-20 |
| Date Added to Maude | 2014-03-10 |
| 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 FAMILY MEMBER OR FRIEND |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVERSE EYEGLASSES |
| Generic Name | CONVERSE BOYS EYEGLASSES BLACK AND WHITE |
| Product Code | HQZ |
| Date Received | 2014-03-04 |
| Model Number | WHY 49-15-130 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |