FDA Adverse Event
Injury
Summary report: N
BED, AC-POWERED ADJUSTABLE HOSPTIAL
MDR report key: 17531293
·
Received August 12, 2023
Report
- Report Number
- MW5138208
- Event Type
- Injury
- Date Received
- August 12, 2023
- Date of Event
- May 14, 2017
- Report Date
- May 28, 2017
- Manufacturer
- CAREMED
- Product Code
- FNL
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
JOERNS HEALTHCARE RECEIVED THE INCLUDED INFORMATION. THE DEVICE(S) IN QUESTION WAS NOT MANUFACTURED NOR IMPORTED BY JOERNS HEALTHCARE, PER SECTION 803.22 (8) (2) WE ARE SUBMITTING THE FOLLOWING INFORMATION. WE ARE FORWARDING THIS INFORMATION FOR FURTHER EVALUATION AND PROCESSING. THE MANUFACTURER, CAREMED, OF THE DEVICE INVOLVED IN THE INCIDENT WAS NOTIFIED BY JOERNS ON MAY 28, 2017. THE BED. PATIENT FELL , AND WAS FOUND IN THE SITTING POSITION ON THE FLOOR. LEFT ARM WEDGED IN BED. NO INJURIES LISTED. NI THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941233 | BED, AC-POWERED ADJUSTABLE HOSPTIAL | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | CAREMED | R125284/R504357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Unknown |