MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-08-27 for REBOUND AIR WALKER LOW TOP B-24290000X manufactured by Ossur.
[4908385]
Pt did not tell fitter of the diabetic medical condition. Orthotic fitter placed standard rebound air walker on the pt. Pt returned 23 weeks later with a quarter size ulcer on the plantar surface of the mla. Waffle pattern of the eva caused blistering due to diabetic medical condition. Fitter replaced the product with a donjoy aircast. Ossur sales rep then fit the pt with the diabetic walker boot.
Patient Sequence No: 1, Text Type: D, B5
[11917829]
Pt did not inform the orthotic fitter the he was diabetic. Fitter provided a regular walker for the pt. When the pt informed the fitter of his diabetes, the fitter proved the pt with a diabetic model walker.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085446-2014-00003 |
| MDR Report Key | 4054094 |
| Report Source | 01,05 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-07-15 |
| Date Mfgr Received | 2014-07-29 |
| Date Added to Maude | 2014-09-04 |
| 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 | REBOUND AIR WALKER LOW TOP |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2014-08-27 |
| Model Number | B-24290000X |
| Catalog Number | B-24290000X |
| 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 RANC CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-27 |