MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for OSSUR DH OFF LOADING POST OP SHOE HCPC L3260 manufactured by Ossur.
[61445083]
Twisted ankle (b)(6) 2016 nondisplaced fracture of lateral malleolus. Ossur dh off loading post operative shoe us patent #(b)(4), hcpc l3260 toe cap seam abrasive pressure resulted in blister; blood filled noted on (b)(6) 2016. Product discontinued (b)(6) 2016 after medications to remove toe cap seam failed to improve fool ulcer. Outcome: osteomyelitis, amputation of 5th metatarsal and 5th toe. Therapy: (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066448 |
| MDR Report Key | 6140681 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-09 |
| Date Added to Maude | 2016-12-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSSUR DH OFF LOADING POST OP SHOE |
| Generic Name | HEALING SHOE |
| Product Code | IPG |
| Date Received | 2016-11-30 |
| Model Number | HCPC L3260 |
| ID Number | PATENT #5778565; 6792699 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR |
| Manufacturer Address | CN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-11-30 |