MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-03-13 for VARI-FLEX PYR EVO C5 S25 VFPE5250 manufactured by Ossur.
[5634160]
Claim of a patient wearing the variflex prosthetic foot tripped and fell and suffered a broken wrist.
Patient Sequence No: 1, Text Type: D, B5
[13087021]
We were notified of this claim 2 years after the incident by the customer. The customer received a lawsuit claim from the patient about the incident. Limited information is available from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2015-00005 |
| MDR Report Key | 4610117 |
| Report Source | 05 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-03-13 |
| Date Mfgr Received | 2015-02-26 |
| Date Added to Maude | 2015-03-18 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARI-FLEX PYR EVO C5 S25 |
| Generic Name | PROSTHESIS, THIGH SOCKET, EXTERNAL C |
| Product Code | ISS |
| Date Received | 2015-03-13 |
| Model Number | VFPE5250 |
| Catalog Number | VFPE5250 |
| 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. Required No Informationntervention | 2015-03-13 |