MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-25 for VARI-FLEX PYR EVO C8 S28HH VFPE8282 manufactured by Ossur.
[5158549]
Below knee amputee patient was going up a flight of stairs when the pyramid adapter broke causing him to fall. The patient hit his head and went to the doctor. No further attention was needed as he is recovering well and will reach full recovery.
Patient Sequence No: 1, Text Type: D, B5
[12214729]
Supplemental report will be submitted upon completion of product evaluation and analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2014-00004 |
| MDR Report Key | 4189231 |
| Report Source | 05 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-09-25 |
| Date of Event | 2014-08-23 |
| Date Mfgr Received | 2014-08-26 |
| Date Added to Maude | 2014-10-27 |
| 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 |
| 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 DR |
| 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 C8 S28HH |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOO |
| Product Code | ISH |
| Date Received | 2014-09-25 |
| Model Number | VFPE8282 |
| Catalog Number | VFPE8282 |
| Lot Number | PB121377/PB130508 |
| 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 | 2014-09-25 |