FDA Adverse Event
Injury
Summary report: N
HOSPITAL BED
MDR report key: 11561851
·
Received March 23, 2021
Report
- Report Number
- MW5100210
- Event Type
- Injury
- Date Received
- March 23, 2021
- Date of Event
- December 30, 2020
- Report Date
- March 19, 2021
- Manufacturer
- DRIVE MEDICAL / MEDICAL DEPOT INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE HOSPITAL BED PROVIDED BY HER INSURANCE COMPANY HAS MANY EXPOSED, MOVING PARTS. MY DAUGHTER'S HAIR GOT CAUGHT IN THOSE PARTS AND PINNED HER IN THE BED, THANKFULLY WE NOTICE BEFORE IT RIPPED HER SCALP OFF. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445517 | HOSPITAL BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | DRIVE MEDICAL / MEDICAL DEPOT INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Required Intervention |