MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-08 for VARI-FLEX MODULAR P20194 manufactured by Ossur.
[22138739]
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.
Patient Sequence No: 1, Text Type: D, B5
[22209777]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2014-00002 |
| MDR Report Key | 3815616 |
| Report Source | 05 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-07 |
| Date of Event | 2014-04-02 |
| Date Mfgr Received | 2014-04-11 |
| Date Added to Maude | 2014-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARI-FLEX MODULAR |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2014-05-08 |
| Model Number | P20194 |
| Catalog Number | P20194 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-08 |