FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3114559
·
Received May 15, 2013
Report
- Report Number
- 9616091-2013-00829
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Date of Event
- April 16, 2013
- Report Date
- April 18, 2013
- Manufacturer
- INVAMEX
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PROVIDER STATES SEAT IS CRACKED. (P/N 1112182).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215644 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | INVAMEX | 9360-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 | Other |