MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for ACTIVE OFFLOADING WALKER LARGE BLACK DH0800BLK manufactured by Ossur Americas.
[48818131]
Patient developed ulcers on the shin and sole of foot within 3 weeks of wearing the active offloading walker boot.
Patient Sequence No: 1, Text Type: D, B5
[50403625]
Patient Sequence No: 1, Text Type: N, H10
[50403626]
Patient developed ulcers on the shin and sole of foot within 3 weeks of wearing the active offloading walker boot. The patient had a preexisting wound on the lateral aspect of his foot and the practitioner was treating the wound with the ossur diabetic walker for 5 weeks. At the 5 week point, the patient started breaking down near the midpoint of his foot creating an ulcer, which was believed to be caused by the friction and rubbing of the walker. The patient does not have a normal gait because of a bone deformity causing him to walk on the outside of his foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00004 |
| MDR Report Key | 5770647 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-06-06 |
| Date Mfgr Received | 2016-06-10 |
| Date Added to Maude | 2016-07-05 |
| 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 |
| 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 | ACTIVE OFFLOADING WALKER LARGE BLACK |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2016-07-05 |
| Model Number | DH0800BLK |
| Catalog Number | DH0800BLK |
| 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 AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-05 |