FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 3342009
·
Received August 13, 2013
Report
- Report Number
- 3342009
- Event Type
- Injury
- Date Received
- August 13, 2013
- Date of Event
- August 8, 2013
- Report Date
- August 9, 2013
- Manufacturer
- MEDICAL DEPOT INC., DBA DRIVE MEDICAL DESIGN AND MANUFACTURING
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A RESIDENT WAS WHEELING HERSELF INDEPENDENTLY IN HER WHEELCHAIR, WHEN THE LEFT FRONT WHEEL CAME OFF AND CAUSED HER TO FALL. SHE SUSTAINED A 1.5CM LACERATION TO HER LEFT TEMPLE AND WAS EVALUATED FOR FURTHER INJURY AT THE HOSPITAL EMERGENCY ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 388778 | DRIVE MEDICAL | HEMI WHEELCHAIR, 18" | IOR | MEDICAL DEPOT INC., DBA DRIVE MEDICAL DESIGN AND MANUFACTURING | SSP218DDA-ELR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Required Intervention |