FDA Adverse Event
Summary report: N
DRIVE MEDICAL
MDR report key: 2890510
·
Received December 26, 2012
Report
- Report Number
- 2438477-2012-00026
- Date Received
- December 26, 2012
- Date of Event
- July 6, 2012
- Report Date
- July 16, 2012
- Manufacturer
- REBORN MEDICAL CO., LTD.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
(B)(4) HAS RECEIVED UPDATED INFO FROM AN ATTORNEY ON THE INJURY FROM A PREVIOUS COMPLAINT INVOLVING A WALKER ALLEGED DISTRIBUTED BY (B)(4). IT WAS INITIALLY COMPLAINED THAT THE CLAIMANT WAS SITTING AND TRIED TO STAND UP WITH WALKER, WHEN THE WALKER LEGS BENT CAUSING HIM TO FALL AND SUSTAIN MINOR INJURIES. (B)(4) HAS RECEIVED A SETTLEMENT LETTER ON (B)(6) 2012 FROM THE ATTORNEY THAT ALLEGED THAT THE CLAIMANT HAD SUSTAINED LEFT PROXIMAL AND DISTAL FIBULAR FRACTURE FROM THE INCIDENT. THIS MDR REPORT IS BASED ON THE COMPLAINT AND MEDICAL RECORDS PROVIDED BY THE CLAIMANT'S ATTORNEY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | WALKER | ITJ | REBORN MEDICAL CO., LTD. | 10210-4 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |