FDA Adverse Event
Injury
Summary report: N
ENCORE
MDR report key: 3952083
·
Received June 19, 2014
Report
- Report Number
- 1419652-2014-00162
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 19, 2014
- Manufacturer
- ARJO MED AB LTD
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT REPORTING THE FOLLOWING: DURING THE PT'S TRANSFER WITH ENCORE ACTIVE LIFT THE RIGHT BRAKE OF THE LIFT HAD NOT LOCKED CORRECTLY, THE LIFT MOVED SUDDENLY AND THE PT DROPPED BACK TO THE CHAIR. THE PT RECEIVED NO INJURIES AS A CONSEQUENCE OF THE EVENT. REF # MFR 9611530-2014-00038.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360906 | ENCORE | FSA | ARJO MED AB LTD | KKA5020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |