MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-27 for VARIFLEX PYRAMID EVO UNITY C8 VFPU8280 manufactured by Ossur Iceland.
[29344731]
Safety alert sent to customers to remind them to only use ossur components in foot assemblies. Competitor products are not compatible and may cause early failure.
Patient Sequence No: 1, Text Type: N, H10
[29344732]
Below knee amputee patient is active and very mobile. The patient was walking on the grass and stepped over a hose on the ground. As he was stepping forward, the pyramid sheared off and he fell. The foot hit him in the head. He was slightly bruised but not injured and did not require any medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00013 |
| MDR Report Key | 5180370 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-05-18 |
| Date Mfgr Received | 2015-05-19 |
| Date Added to Maude | 2015-10-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIFLEX PYRAMID EVO UNITY C8 |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2015-10-27 |
| Returned To Mfg | 2015-07-16 |
| Model Number | VFPU8280 |
| Catalog Number | VFPU8280 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |