FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 4201927
·
Received October 27, 2014
Report
- Report Number
- 1531186-2014-05109
- Date Received
- October 27, 2014
- Date of Event
- October 1, 2014
- Report Date
- October 1, 2014
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PER END USER, THE SUCTION CUP CAME OFF THE LEG WHEN HE PICKED UP THE TRANSFER BENCH. IT HAD TOO MUCH SUCTION AND THE CUP CAME OFF THE LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683200 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 98071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |