MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-04-07 for KIT ROTATE TALL FEM C6 S27 RHFE6270 manufactured by Ossur.
[4527033]
Upper section, rotate and clamp separated from prosthetic foot completely.
Patient Sequence No: 1, Text Type: D, B5
[11754451]
Upon failure analysis investigation performed on (b)(6) 2014 - it was determined that this is a mdr reportable event since this risk is not acceptable to the pt. No injury occurred with this incident, however, capa (b)(4) was opened to address this risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003764610-2014-00001 |
| MDR Report Key | 3793458 |
| Report Source | 01,05 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-04-07 |
| Date of Event | 2014-03-07 |
| Date Mfgr Received | 2014-03-07 |
| Date Added to Maude | 2014-06-03 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT ROTATE TALL FEM C6 S27 |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2014-04-07 |
| Returned To Mfg | 2014-03-24 |
| Model Number | RHFE6270 |
| Catalog Number | RHFE6270 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-07 |