FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3000639
·
Received March 12, 2013
Report
- Report Number
- 9616091-2013-00432
- Event Type
- Malfunction
- Date Received
- March 12, 2013
- Report Date
- February 14, 2013
- Manufacturer
- INVAMEX
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES, THE SEAT IS CRACKED. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102997 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | INVAMEX | 9650-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |