FDA Adverse Event
Malfunction
Summary report: N
PEV 2000
MDR report key: 2837039
·
Received October 16, 2012
Report
- Report Number
- 1931307-2012-00001
- Event Type
- Malfunction
- Date Received
- October 16, 2012
- Report Date
- October 12, 2012
- Manufacturer
- WHEELCHAIRS OF KANSAS
- Product Code
- ITI
- PMA / PMN Number
- K983497
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUAL FOR THE PRODUCT SPECIFIES TO "INSTALL FOOTREST/ELEVATING LEGREST AND ARMRESTS BEFORE OPERATING".
Description of Event or Problem · 1
DEALER CALLED ON (B)(6) 2012 TO REQUEST AN RA FOR PARTS. ON (B)(6) 2012 THE DEALER CALLED TO REQUEST INFO ON THE PARTS RETURNED AND AT THAT TIME INDICATED THAT THE END USER HAD SUSTAINED AN ABRASION INJURY FROM USE OF THEIR POWER WHEELCHAIR. THE END USER INCURRED AN ABRASION THAT BECAME INFECTED, RESULTING IN A 3 DAY HOSPITAL STAY. THE FRONT RIGGING (FOOTRESTS) ON THE CHAIR WERE REMOVED/LEFT OFF OF THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEV 2000 | PEV | ITI | WHEELCHAIRS OF KANSAS | PEV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |