FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 2967623
·
Received February 14, 2013
Report
- Report Number
- 2438477-2013-00005
- Event Type
- Injury
- Date Received
- February 14, 2013
- Date of Event
- December 10, 2012
- Report Date
- January 15, 2013
- Manufacturer
- FOSHAN R POON MEDICAL PRODUCTS CO, LTD
- Product Code
- NXE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DRIVE MEDICAL HAS RECEIVED A COMPLAINT FROM AN END USER ABOUT AN INCIDENT INVOLVING A REPLACEMENT WALKER GLIDE ALLEGEDLY IMPORTED AND DISTRIBUTED BY (B)(4). IT IS ALLEGED THAT THE END USER WAS USING THE DRIVE MEDICAL WALKER GLIDE WITH A WALKER MADE BY A DIFFERENT MFR. THERE WAS A SLIT IN THE RUG AND THE GLIDE WENT UNDER IT CAUSING THE CLAIMANT TO FALL OVER THE WALKER AND ALLEGEDLY BROKE HER LEFT LEG. THIS MDR REPORT IS BASED ON THE END USER COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65741 | DRIVE MEDICAL | WALKER TIPS | NXE | FOSHAN R POON MEDICAL PRODUCTS CO, LTD | 100014 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | MODEL # MO 3864104| WALKER MADE BY (B)(4) |