FDA Adverse Event
Malfunction
Summary report: N
BENTLEY
MDR report key: 17531429
·
Received August 12, 2023
Report
- Report Number
- MW5138344
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- October 21, 2015
- Manufacturer
- PDG MOBILITY
- Product Code
- IOR
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
HE DEALER STATES THAT THE PATIENT IS HARD ON HIS CHAIR AND THE PATIENT BROKE THE CANE MOUNTING HARDWARE ON THE RIGHT SIDE. NO INJURY ALLEGED. RECEIVED A CALL FROM THE DEALER WHO STATED THAT THE CHAIR IS NOT A POWER CHAIR THAT IT IS A BENTLEY MANUAL TILT-IN-SPACE WHEELCHAIR - PDG MOBILITY. THIS IN NOT AN INVACARE CHAIR AND THE DEALER WAS ONLY TRYING TO OBTAIN A MATRIX BACK FOR THIS BENTLEY CHAIR. NO FURTHER INFORMATION CAN BE PROVIDED. THE BACK THAT IS BROKEN IS THE ORIGINAL BACK FOR THE CHAIR, THEY ARE JUST INQUIRING ON HOW TO GET A MOTION CONCEPTS SEAT BACK. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1050532 | BENTLEY | WHEELCHAIR, MECHANICAL | IOR | PDG MOBILITY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |