FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 2255145
·
Received August 17, 2011
Report
- Report Number
- 2438477-2011-00012
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- June 10, 2011
- Report Date
- July 18, 2011
- Manufacturer
- JAN MAO INDUSTRIES, CO., LTD.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DRIVE MEDICAL HAS RECEIVED A CUSTOMER COMPLAINT ON A WALKER ORIGINALLY IMPORTED BY DRIVE MEDICAL. IT WAS ALLEGED THAT ONE OF THE LEGS ON THE WALKER BENT CAUSING THE PT TO FALL TO THE GROUND, BREAKING HIS LEFT SHOULDER. THIS MDR REPORT IS BASED ON THE CUSTOMER COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | WALKER | ITJ | JAN MAO INDUSTRIES, CO., LTD. | 10243 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |