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 |