FDA Adverse Event
Other
Summary report: N
FUZE
MDR report key: 2794754
·
Received August 9, 2012
Report
- Report Number
- 9681827-2012-00001
- Event Type
- Other
- Date Received
- August 9, 2012
- Manufacturer
- PDG PRODUCT DESIGN GROUP INC
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
WE SUSPECT THAT THE PDG FUZE WHEEL CHAIRS BUILT IN MAY 2012 MAY HAVE SOME DEFECTIVE HEX BOLTS INSTALLED ON THE LOWER FRAME. THE HEX BOLT HEAD IS GETTING SHEARED AND MIGHT CAUSE THE AXLE PLATE TO DETACH AND IN TURN COLLAPSE THE CHAIR WHEN SOMEONE SITS ON IT. THE FUZE WHEELCHAIRS AFFECTED ARE WITH SERIAL NUMBERS STARTING FROM (B)(4). THE ROOT CAUSE HAS BEEN IDENTIFIED AS A BAD BATCH OF 5/16 HEX BOLTS THAT WAS USED TO BUILD FUZE WHEEL CHAIRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FUZE | FUZE 50 AND FUZE 20 | IOR | PDG PRODUCT DESIGN GROUP INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |