FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 3940990
·
Received July 17, 2014
Report
- Report Number
- 1531186-2014-02567
- Date Received
- July 17, 2014
- Report Date
- June 10, 2014
- Manufacturer
- PINGHU WEIFENG MATERIAL TECHNOLOGY
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER EMAIL CUSTOMER STATES: HAVE A 9871 LOT# PW130501 THAT HAS A CRACKED SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419502 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | PINGHU WEIFENG MATERIAL TECHNOLOGY | 98071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |