FDA Adverse Event
Malfunction
Summary report: N
T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639974
MDR report key: 5123816
·
Received October 2, 2015
Report
- Report Number
- 9616091-2015-02409
- Event Type
- Malfunction
- Date Received
- October 2, 2015
- Report Date
- September 4, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
DEALER STATES THE RIGHT SIDE WHEEL LOCK IS BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653869 | T4/WD08/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639974 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | T420RDA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |