FDA Adverse Event
Injury
Summary report: N
VERSACARE BED
MDR report key: 3082968
·
Received April 24, 2013
Report
- Report Number
- 1824206-2013-02336
- Event Type
- Injury
- Date Received
- April 24, 2013
- Date of Event
- March 28, 2013
- Report Date
- March 28, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH INVESTIGATED AND FOUND NO ISSUE WITH THE BED OR MATTRESS, THE BED FUNCTIONS AS DESIGNED. THE ACCOUNT STATED THE PATIENT WAS TREATED FOR THE PRESSURE ULCER BUT NO DETAILS WERE GIVEN.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE MATTRESS IS TOO FIRM AND CAUSED THE WOUND ON THE PATIENT TO WORSEN. THE ACCOUNT ALLEGED THE CENTER SECTION OF THE MATTRESS SEEMED TO BE HARDER THAN THE REST OF THE MATTRESS. PATIENT HAD A STAGE 3 PRESSURE ULCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177126 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |