FDA Adverse Event
Injury
Summary report: N
OTIS AND PIPER OP4001 EYEGLASSES
MDR report key: 13087451
·
Received December 23, 2021
Report
- Report Number
- MW5106267
- Event Type
- Injury
- Date Received
- December 23, 2021
- Date of Event
- December 19, 2021
- Report Date
- December 21, 2021
- Manufacturer
- ALTAIR/MARCHON ITALIA SRL
- Product Code
- HQZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MI, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FROM A REPORTER ON 02/18/2022 FOR A REPORT NUMBER MW5106267.
Description of Event or Problem · 0
MY SON HAS A PAIR OF OTIS AND PIPER GLASSES FRAMES, WHICH HAVE BROKEN TWICE (TWO SEPARATE FRAMES, AFTER BEING REPLACED) IN THE SAME MANNER. BOTH TIMES, THEY BROKE EXPOSING A METAL SCREW THAT WAS POINTED TOWARDS HIS EYE, AND CUT HIS EYE. IF HE HAD FALLEN OR BEEN BUMPED SLIGHTLY OVER, IT WOULD HAVE PUNCTURED HIS EYEBALL. THE FIRST TIME, THE FRAMES BROKE AFTER ANOTHER CHILD AT SCHOOL BUMPED HIM. THIS TIME, THE REPLACEMENT FRAMES BROKE AFTER HE FELL DOWN. BOTH TIMES, THE SAME SCREW WAS EXPOSED AND PUNCTURED HIS EYE. FDA SAFETY REPORT ID # (B)(4).
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FROM A REPORTER ON 02/18/2022 FOR A REPORT NUMBER MW5106267.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969331 | OTIS AND PIPER OP4001 EYEGLASSES | FRAME, SPECTACLE | HQZ | ALTAIR/MARCHON ITALIA SRL | OP4001 | ||
| 1969332 | OTIS AND PIPER OP4001 EYEGLASSES | FRAME, SPECTACLE | HQZ | ALTAIR/MARCHON ITALIA SRL | OP4001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Male | Other | EYEGLASSES| VYVANSE |