FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 4973353
·
Received August 5, 2015
Report
- Report Number
- 9616091-2015-01993
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Report Date
- July 10, 2015
- Manufacturer
- INVAMEX
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.
Description of Event or Problem · 1
PROVIDER STATES THE LEVER BROKE OFF AT THE WELD ON THE RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517499 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |