FDA Adverse Event
Malfunction
Summary report: N
PRONTO M41 BLUE BASE 9153645762
MDR report key: 5192993
·
Received October 30, 2015
Report
- Report Number
- 3008262382-2015-01871
- Event Type
- Malfunction
- Date Received
- October 30, 2015
- Report Date
- August 14, 2015
- Manufacturer
- INVACARE REHABILITATION EQUIPMENT CO.
- Product Code
- ITI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
THE PROVIDER STATES THE SEAT BROKE BY WHERE THE FRAME MEETS THE SEAT POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 722893 | PRONTO M41 BLUE BASE 9153645762 | WHEELCHAIR, POWERED | ITI | INVACARE REHABILITATION EQUIPMENT CO. | M41RSOLIDB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |