FDA Adverse Event
Other
Summary report: N
HILL-ROM, INC.
MDR report key: 312271
·
Received January 11, 2001
Report
- Report Number
- 1045510-2001-00001
- Event Type
- Other
- Date Received
- January 11, 2001
- Date of Event
- November 14, 2000
- Report Date
- January 10, 2001
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS ALLEGED BY FAMILY MEMBER OF PT THAT BED HAD CAUSED BLISTERS TO DEVELOP ON PT'S RIGHT FOOT. PT IS QUADRAPLEGIC AND IS UNABLE TO FEEL PRESSURE ON THEIR EXTREMETIES. HOME HEALTH AGENCY MADE NO NOTE OF BLISTERS IN THIER REPORT. SALES REP DURING HOME VISIT FOUND BLISTER ON FOOT. TECH CHECKED BED AND FOUND IT WAS WORKING PROPERLY WITHIN TEMPERATURE RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1137 | HILL-ROM, INC. | AIR FLUIDIZED BED | INX | HILL-ROM, INC. | CLINITRON AT HOME | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization |