FDA Adverse Event
Injury
Summary report: N
INVACARE WALKERS
MDR report key: 982256
·
Received January 22, 2008
Report
- Report Number
- 1525712-2008-00005
- Event Type
- Injury
- Date Received
- January 22, 2008
- Date of Event
- January 2, 2008
- Report Date
- January 14, 2008
- Manufacturer
- NAN HAI GENTEEL ALUMINUM GOODS CO. LTD.
- Product Code
- ITJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS A DISTRIBUTED PRODUCT. MFR HAS BEEN NOTIFIED OF ALLEGED INCIDENT.
Description of Event or Problem · 1
THE CONSUMER WAS USING THE ROLLATOR AT THE NURSING HOME WHEN THE METAL LEG ALLEGEDLY SNAPPED HALF WAY UP THE LEG, CAUSING THE CONSUMER TO FALL AND CUT HIS HEAD, REQUIRING 8 STITCHES. SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE WALKERS | 890.3825 | ITJ | NAN HAI GENTEEL ALUMINUM GOODS CO. LTD. | 68100-TA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Required Intervention |