MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-12-01 for EQUALIZER AIR WALKER A-W05000BLK manufactured by Ossur Americas.
[32397917]
Patient Sequence No: 1, Text Type: N, H10
[32397918]
Patient claims the sole of the equalizer air walker delaminated causing her to trip and sprain her sound ankle. She had a preexisting injury and claims this delayed her return to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2015-00003 |
| MDR Report Key | 5257774 |
| Report Source | CONSUMER |
| Date Received | 2015-12-01 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-08-09 |
| Date Mfgr Received | 2015-09-11 |
| Device Manufacturer Date | 2015-03-24 |
| Date Added to Maude | 2015-12-01 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR AMERICAS |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EQUALIZER AIR WALKER |
| Generic Name | JOINT ANKLE EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2015-12-01 |
| Returned To Mfg | 2015-09-14 |
| Model Number | A-W05000BLK |
| Catalog Number | A-W05000BLK |
| Lot Number | LU150324 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-01 |