FDA Adverse Event
Malfunction
Summary report: N
DEROYAL
MDR report key: 3810200
·
Received February 5, 2014
Report
- Report Number
- 3005225477-2014-00001
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- December 18, 2013
- Report Date
- January 6, 2014
- Manufacturer
- DEROYAL GUATEMALA
- Product Code
- FMQ
- PMA / PMN Number
- K963468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT A HIGHLY AGITATED PATIENT FOUND A WAY TO BREAK THE FOAM STRAP OF THE RESTRAINT. AFTER THEY BROKE THE STRAP THEY WERE ABLE TO GET OUT OF THEIR BED AND FELL. NO INJURIES WERE REPORTED. DEROYAL: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.
Description of Event or Problem · 1
THE MEDICAL CENTER REPORTED THAT A HIGHLY AGITATED PATIENT FOUND A WAY TO BREAK THE FOAM STRAP OF THE RESTRAINT. AFTER THEY BROKE THE STRAP THEY WERE ABLE TO GET OUT OF THEIR BED AND FELL. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75977 | DEROYAL | FMQ - RESTRAINT, PROTECTIVE | FMQ | DEROYAL GUATEMALA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |