MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2015-03-31 for REHAB CONTOUN AIR LIGHT R B-220500000 manufactured by Ossur.
[5683545]
The pt was wearing the rehab knee brace while walking up a flight of stairs. The pt claims the velcro on the brace failed causing him to fall. He was able to catch and brace himself but he landed on his knee and fractured his patella. He went in for surgery the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00008 |
| MDR Report Key | 4658405 |
| Report Source | 04,05 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-30 |
| Date of Event | 2012-09-04 |
| Date Mfgr Received | 2012-11-05 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2015-04-06 |
| 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 |
| 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 | REHAB CONTOUN AIR LIGHT R |
| Product Code | ISS |
| Date Received | 2015-03-31 |
| Returned To Mfg | 2012-12-18 |
| Model Number | B-220500000 |
| Catalog Number | B-220500000 |
| 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. Required No Informationntervention | 2015-03-31 |