FDA Adverse Event
Injury
Summary report: N
DRIVE MEDICAL
MDR report key: 2619777
·
Received June 7, 2012
Report
- Report Number
- 3003910843-2012-00002
- Event Type
- Injury
- Date Received
- June 7, 2012
- Date of Event
- July 12, 2009
- Report Date
- January 26, 2011
- Manufacturer
- SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO.
- Product Code
- NXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ONE OF OUR DISTRIBUTORS IN THE UNITED STATES, (B)(6), HAS RECEIVED AN ATTORNEY LETTER ALLEGING THAT THE CLAIMANT WAS INJURED FROM ONE OF ROLLATORS MANUFACTURED BY SHANGHAI SHUNLONG. IT WAS ALLEGED THAT THE ROLLATOR FRONT-LEFT BAR CRACKED CAUSING THE CLAIMANT TO FALL AND SUSTAIN SPRAIN/STRAIN IN HIS NECK, BACK AND ELBOW. PT'S MEDICAL RECORD SHOWED NO FRACTURE. THIS MDR REPORT IS BASED ON THE MDR REPORT SUBMITTED BY (B)(4) AND ADD'L INFO PROVIDED BY THIS DISTRIBUTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRIVE MEDICAL | ROLLATOR | NXE | SHANGHAI SHUNLONG PHYSICAL THERAPY EQUIPMENT CO. | 726BL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization |