FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 5415776
·
Received February 8, 2016
Report
- Report Number
- 9616091-2016-00173
- Event Type
- Malfunction
- Date Received
- February 8, 2016
- Date of Event
- December 22, 2015
- Report Date
- February 15, 2016
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULT OF THE EVALUATION WAS THAT THE TIRES WERE FLAT BECAUSE THE TUBES WON'T HOLD AIR, CAUSING THE TIRES TO COME OFF OF THE RIMS., WHICH CONFIRMED THE ORIGINAL COMPLAINT ISSUE.
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PROVIDER ALLEGES THE LEFT AND RIGHT TIRES KEEP COMING OFF OF THE RIM.
Description of Event or Problem · 1
PROVIDER ALLEGES THE LEFT AND RIGHT TIRES KEEP COMING OFF OF THE RIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76340 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |