FDA Adverse Event
Injury
Summary report: N
INVACARE FULL/SEMI ELECTRIC HOME CARE BED
MDR report key: 226065
·
Received June 3, 1999
Report
- Report Number
- 1525712-1999-00044
- Event Type
- Injury
- Date Received
- June 3, 1999
- Date of Event
- March 7, 1999
- Report Date
- June 1, 1999
- Manufacturer
- INVACARE CORPORATION
- Product Code
- FNL
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
MFR RECEIVED A REPORT FROM THE FDA STATING THAT THE USER OF AN ELECTRIC BED HAD GOTTEN TRAPPED BETWEEN THE BED RAIL AND THE MATTRESS. AS A RESULT OF THIS INCIDENT, THE USER SUSTAINED A BROKEN LEG. NO MALFUNCTION OF THE EQUIPMENT WAS REPORTED OR ALLEGED. SEVERAL ATTEMPTS BY THE MFR TO CONTACT THE USER HAVE NOT BEEN RESPONDED TO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE FULL/SEMI ELECTRIC HOME CARE BED | AC POWERED ADJ. HOSPITAL BED | FNL | INVACARE CORPORATION | BED, FULL/SEMI ELECTRIC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |