FDA Adverse Event
Other
Summary report: N
DERMFLOAT CONTROL UNIT
MDR report key: 3536674
·
Received October 21, 2013
Report
- Report Number
- 3009525805-2013-00052
- Event Type
- Other
- Date Received
- October 21, 2013
- Date of Event
- October 8, 2013
- Report Date
- October 18, 2013
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY (REGENCY PLACE NURSING AND REHAB), PER THE FACILITY THE CNA WAS IN THE RESIDENT'S ROOM ADJUSTING THE BED. SHE BUMPED INTO THE FRAYED ELECTRICAL CORD ON THE CONTROL UNIT AND RECEIVED A MILD SHOCK. SHE FELL BACK AND HIT HER HEAD ON THE WALL. THE CNA WAS TAKEN TO AN AFTER HOURS CLINIC COMPLAINING OF HEADACHES. THE CNA HAS RETURNED TO WORK. COMPLAINT NUMBER (B)(4) WAS ENTERED OUR SYSTEM TO RETRIEVE THE CONTROL UNIT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539210 | DERMFLOAT CONTROL UNIT | CONTROL UNIT FOR AIR MATTRESS | FNM | JOERNS HEALTHCARE | DFLAL-CU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |