FDA Adverse Event
Other
Summary report: N
GUARDIAN COMMODE
MDR report key: 1023753
·
Received March 4, 2008
Report
- Report Number
- 3006459587-2008-00004
- Event Type
- Other
- Date Received
- March 4, 2008
- Date of Event
- February 13, 2008
- Report Date
- March 3, 2008
- Manufacturer
- PROFIT COUNTRY ENTERPRISE LTD
- Product Code
- INB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AFTER REVIEWING THE DEVICE, THERE ARE NO EXTERNAL SIGNS THAT WOULD HAVE CAUSED THE DEVICE TO FAIL. IT APPEARS THE COMMODE WAS USED CORRECTLY. FROM THE DIRECTION OF THE BENT LEG, IT APPEARS THE USER HAD LEANED BACK AND TO HIS LEFT RESULTING IN MORE PRESSURE / WEIGHT BEING APPLIED TO THE ONE LEG. THE LEG BENT FROM THE INCREASED LOAD.
Description of Event or Problem · 1
A HOSPITAL REPORTED A USER OF A GUARDIAN COMMODE FELL AND HIT HIS HEAD AFTER THE LEFT BACK LEG BENT INWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDIAN COMMODE | COMMODE | INB | PROFIT COUNTRY ENTERPRISE LTD | 98202 | 0707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |