FDA Adverse Event
Malfunction
Summary report: N
ELECTRIC POSITIONING CHAIR
MDR report key: 3022200
·
Received March 26, 2013
Report
- Report Number
- 1525712-2013-02330
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Report Date
- February 27, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- INO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.
Description of Event or Problem · 1
END USER STATES THE FRONT CASTER IS BENT AT THE BOLT PER END USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124652 | ELECTRIC POSITIONING CHAIR | 890.3110 | INO | INVACARE TAYLOR STREET | HTR5500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |