MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-21 for REBOUND DIABETIC WALKER LARGE B-242500004 manufactured by Ossur.
[5153691]
Patient was fit with a large diabetic walker. Boot was fit 1 inch away from the longest toe. High arched foot with prominent metatarsal heads. Patient claims the strap rivet sheared through the boot liner causing a dime size ulcer on his foot.
Patient Sequence No: 1, Text Type: D, B5
[12399272]
Failure is still under investigation, supplemental report will be provided upon completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2085446-2014-00004 |
| MDR Report Key | 4209624 |
| Report Source | 01,05 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-26 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-10-30 |
| 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 DR |
| 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 DIABETIC WALKER LARGE |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2014-10-21 |
| Returned To Mfg | 2014-10-14 |
| Model Number | B-242500004 |
| Catalog Number | B-242500004 |
| Lot Number | 352 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-10-21 |