FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2749631
·
Received September 19, 2012
Report
- Report Number
- 1531186-2012-00942
- Date Received
- September 19, 2012
- Report Date
- September 26, 2012
- Manufacturer
- SUN ZING PLASTIC IRONWARE
- Product Code
- IKX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) ISSUED MFR REPORT #1531186-2012-00942 WITH THE MANUFACTURER AS UNKNOWN. THE ACTUAL MANUFACTURER IS SUN ZING PLASTIC IRONWARE LOCATED IN (B)(4). NOTIFICATION HAS BEEN SENT TO THEIR US AGENT.
Description of Event or Problem · 1
DEALER STATES THE SUCTION ON THE GRAB BAR STOPPED WORKING AND WOULD NOT HOLD ANY LONGER. NO REPORT OF ILL EFFECT TO THE USER.
Description of Event or Problem · 1
DEALER STATES THE SUCTION ON THE GRAB BAR STOPPED WORKING AND WOULD NOT HOLD ANY LONGER. NO REPORT OF ILL EFFECT TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | IKX | SUN ZING PLASTIC IRONWARE | 218-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 DA | Other |