FDA Adverse Event
Injury
Summary report: N
AQUATEC TILT COMMODE
MDR report key: 1053349
·
Received May 28, 2008
Report
- Report Number
- 1525712-2008-00043
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- December 7, 2007
- Report Date
- May 19, 2008
- Manufacturer
- AQUATEC GMBH
- Product Code
- INB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER RECEIVED SUMMONS ALLEGING SERIOUS INJURY. INCIDENT REPORTEDLY OCCURRED DURING AN ASSISTED TRANSFER. DEVICE HAS NOT BEEN PROVIDED FOR INSPECTION UNCLEAR IF DEVICE WAS IMPROPERLY LOADED AND OR MISUSED. AS A CONSERVATIVE MEASURE MDR FILED BASED ON INJURY CLAIM.
Description of Event or Problem · 1
THE CONSUMER WAS ALLEGEDLY BEING ASSISTED BY A CAREGIVER WHILE ON THE COMMODE. AS THE CONSUMER WAS BEING TRANSFERRED INTO THE SHOWER, A BOLT ALLEGEDLY BROKE ON THE COMMODE, CAUSING THE CONSUMER TO FALL AND SUFFER "SERIOUS PERSONAL INJURIES", INCLUDING A FRACTURE ON HER RIGHT FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AQUATEC TILT COMMODE | NONE | INB | AQUATEC GMBH | UNKCOM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |