FDA Adverse Event
Malfunction
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3971475
·
Received July 31, 2014
Report
- Report Number
- 3007231105-2014-00037
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Report Date
- June 23, 2014
- Manufacturer
- AQUATEC OPERATIONS GMBH
- 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
IT WAS REPORTED THAT THE 9630-4 COMMODE FRONT CROSS BRACE BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448481 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | AQUATEC OPERATIONS GMBH | 9630-4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |