FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 5566681
·
Received April 11, 2016
Report
- Report Number
- 9616091-2016-00430
- Event Type
- Malfunction
- Date Received
- April 11, 2016
- Report Date
- April 25, 2016
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.
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 TIRE IS SEPARATING FROM THE RIM , WHICH CONFIRMED THE ORIGINAL COMPLAINT ISSUE. HOWEVER, THE UNDERLYING CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THE DEALER STATED THE TIRE IS FREE FROM THE RIM.
Description of Event or Problem · 1
THE DEALER STATED THE TIRE IS FREE FROM THE RIM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223432 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT_PTO_33131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |