FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3083772
·
Received April 29, 2013
Report
- Report Number
- 9616091-2013-00716
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 4, 2013
- Manufacturer
- INVAMEX
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES HAS HAD SINCE (B)(6) 2012 AND SEAT CRACKED. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184037 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | INVAMEX | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |