D
Patient 1
BELOW KNEE AMPUTEE PATIENT WAS WALKING WHEN THE PROSTHESIS BECAME UNLOCKED. THE LEG FELL OFF CAUSING HER TO FALL INTO A RETAINING WALL. SHE WAS KNOCKED UNCONSCIOUS.
MAUDE MDR 3815616
- MDR report key
- 3815616
- Report number
- 3003764610-2014-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-04-02
- Date received
- 2014-05-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KAREN MONTES
- Address
- 27051 TOWNE CENTRE DRIVE FOOTHILL RANCH CA 92610 US
- Phone
- 949-949-9493
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-05-08 | 0 | 1. O |
Event Narratives#
N
Patient 1
CONCLUSION: WE NEED THIS ICELOCK 400 TO PERFORM FURTHER INVESTIGATION FOR THE ROOT CAUSE FOR THIS INCIDENT. WHEN RECEIVED THIS RA FORM 219 WILL BE UPDATED. IN PROJECT (B)(4) THE SURFACE TREATMENT OF BOTH LOCKING WASHER AND THE PIN WAS CHANGED TO PREVENT THIS TO HAPPEN. ALSO IT IS VERY IMPORTANT TO CHANGE THE LOCKING PIN AS RECOMMENDED IN IFU A LEAST YEARLY.