MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-07-10 for VARI-FLEX PYR EVO C9 S29 VFPE9290 manufactured by Ossur.
[6013352]
Below knee amputee pt wearing a prosthetic foot got out of his car and walked to the passenger side. As he was handing off his keys. He tried gave out underneath him causing him to fail. He tried pushing off to land on the grass but fell on the asphalt. He turned and landed on his hip and side to try and break the fall. He injured his hip, right shoulder and arm. Pt has been wearing the foot about 2 years. Injury occurred on (b)(6) 2015, the pt went to emergency room on (b)(6) 2015. He received local injections to his hip to help relieve the pain and was given pain medicine. He is bruised but expects to reach full recovery. Next f/u appointment is scheduled for (b)(6) 2015 with his prosthetist and he will f/u with his doctor from there if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00010 |
| MDR Report Key | 4935829 |
| Report Source | 04 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2015-06-18 |
| Date Added to Maude | 2015-07-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE |
| 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 PYR EVO C9 S29 |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2015-07-10 |
| Model Number | VFPE9290 |
| Catalog Number | VFPE9290 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-07-10 |