MAUDE Adverse Event Report: CASCADE DAFO, INC DAFO; HINGED ANKLE-FOOT ORTHOSIS

Model Number DAFO 2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

Instructions for use provided by the manufacturer say, "any red mark or sign of irritation that does not go away within 20 minutes after the brace has been removed may indicate a fit problem requiring action.Discontinue use, and immediately inform your practitioner if this happens." a brace fit so tight as to cause a bone fracture would certainly be accompanied by redness and irritation.Patient has an underlying bone health condition, osteopenia of the foot.Brace volume, size and shape affecting the fit to the patient was manufactured in accordance with the standard process, verified through comparison of original mold cad/cam scan and final mold used to manufacture the brace.Mold of foot is on file indicating size.

Event Description

Physical therapist, (b)(6), called cascade dafo, inc.Technical support staff to ask for a re-fabrication of the left ankle-foot orthosis under warranty, saying the doctor reports tight fit of afo has caused left cuboid bone stress fracture.

• Brand Name: DAFO
• Type of Device: HINGED ANKLE-FOOT ORTHOSIS
• Manufacturer (Section D): CASCADE DAFO, INC; 1360 sunset ave.; ferndale WA 98248
• Manufacturer (Section G): CASCADE DAFO, INC.; 1360 sunset ave.; ferndale WA 98248
• Manufacturer Contact: loretta sheldon ; 1360 sunset ave; ferndale, WA 98248 ; 3605439245
• MDR Report Key: 6593002
• MDR Text Key: 76015029
• Report Number: 3003475336-2017-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physical Therapist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DAFO 2
• Device Catalogue Number: DAFO 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 15