FDA Adverse Event
Other
Summary report: N
AIR PRESSURE BED
MDR report key: 25171
·
Received July 31, 1995
Report
- Report Number
- 25171
- Event Type
- Other
- Date Received
- July 31, 1995
- Date of Event
- June 19, 1995
- Report Date
- July 29, 1995
- Manufacturer
- KCI MEDICAL SUPPLIES
- Product Code
- INX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT IN A CO'S AIR PRESSURE BED HAD SKIN BREAKDOWN AT AN AREA WHERE THORACIC CUSHIONS DID NOT ADEQUATELY COVER THE HARD SUPPORTS. THE BED REP DETERMINED THAT THE CUSHION WAS FAULTY & REQUIRED REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIR PRESSURE BED | BED | INX | KCI MEDICAL SUPPLIES | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |