FDA Adverse Event
Injury
Summary report: N
RAY-BAN
MDR report key: 112685
·
Received August 11, 1997
Report
- Report Number
- 1643383-1997-00007
- Event Type
- Injury
- Date Received
- August 11, 1997
- Date of Event
- March 22, 1997
- Report Date
- July 21, 1997
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CONSUMER ALLEGES AN INJURY REQUIRING MEDICAL TREATMENT, CAUSED BY HER SUNGLASSES WHEN HER HORSE REARED AND HIT HER WITH HIS HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RAY-BAN | SUNGLASS | HQY | BAUSCH & LOMB, INC. | WAYFARER | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |