MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-13 for REBOUND WALKER B-242900003 manufactured by Ossur.
[2121093]
Pt was wearing a walker boot as intended and the opening of the boot that curves just slightly on the lower section made contact with the incision point on the ankle. This caused the pt's stitches to open. She visited her doctor and another surgery had to be performed. She will reach full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3026585-2011-00005 |
| MDR Report Key | 2176672 |
| Report Source | 05 |
| Date Received | 2011-07-13 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-03-19 |
| Date Mfgr Received | 2011-05-31 |
| Date Added to Maude | 2011-07-27 |
| 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 | 19762 PAULING |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492683155 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REBOUND WALKER |
| Product Code | ITW |
| Date Received | 2011-07-13 |
| Model Number | B-242900003 |
| Catalog Number | B-242900003 |
| 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 | FOOTHILL RANCH CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-13 |