FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 2189663
·
Received July 29, 2011
Report
- Report Number
- 2438477-2011-00011
- Event Type
- Injury
- Date Received
- July 29, 2011
- Report Date
- June 30, 2011
- Manufacturer
- JAN MAO INDUSTRIES CO., LTD.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DRIVE MEDICAL HAS RECEIVED AN END-USER COMPLAINT ON A ROLLATOR ORIGINALLY IMPORTED BY DRIVE MEDICAL. IT WAS ALLEGED THAT THE LEFT-FRONT CASTER KICKED OUT CAUSING THE END-USER TO FALL AND HURT HIS ELBOW. ALLEGEDLY THE END-USER HAD SURGERY LAST WEEK. THIS MDR REPORT IS BASED ON THE CUSTOMER COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | ROLLATOR | ITJ | JAN MAO INDUSTRIES CO., LTD. | 544 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |