MAUDE Adverse Event Report: OSSUR OSSUR DH OFF LOADING POST OP SHOE; HEALING SHOE

Model Number HCPC L3260

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bone Fracture(s) (1870); Tissue Damage (2104); Impaired Healing (2378)

Event Date 11/09/2016

Event Type  Injury  

Event Description

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.

• Brand Name: OSSUR DH OFF LOADING POST OP SHOE
• Type of Device: HEALING SHOE
• Manufacturer (Section D): OSSUR; cn
• MDR Report Key: 6140681
• MDR Text Key: 61445083
• Report Number: MW5066448
• Device Sequence Number: 1
• Product Code: IPG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HCPC L3260
• Other Device ID Number: PATENT #5778565; 6792699
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Weight: 105