FDA Adverse Event
Summary report: N
DAILY ACTIVITY ASSIST DEVICES
MDR report key: 2342952
·
Received November 19, 2011
Report
- Report Number
- 1525712-2011-00925
- Date Received
- November 19, 2011
- Date of Event
- October 24, 2011
- Report Date
- November 21, 2011
- Manufacturer
- KENSTONE METAL
- Product Code
- ILS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(6), 2011 - JLB - FOLLOW-UP #001 - THE CORRECT MANUFACTURER OF THIS DEVICE IS KENSTONE. ORIGINALLY IT WAS IDENTIFIED AS POPULAR PLASTICS, WHICH IS INCORRECT.
Description of Event or Problem · 1
THE HARDWARE THAT ATTACHES THE SEAT TO THE FRAME ALLEGEDLY CAME LOOSE. A TECH ATTEMPTED TO TIGHTEN, BUT WAS UNABLE TO DO SO SATISFACTORILY.
Description of Event or Problem · 1
THE HARDWARE THAT ATTACHES THE SEAT TO THE FRAME ALLEGEDLY CAME LOOSE. A TECH ATTEMPTED TO TIGHTEN, BUT WAS UNABLE TO DO SO SATISFACTORILY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DAILY ACTIVITY ASSIST DEVICES | 890.5050 | ILS | KENSTONE METAL | 6895 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |