MAUDE Adverse Event Report: OSSUR AMERICAS EQUALIZER WALKER MEDIUM BLACK; JOINT, ANKLE, EXTERNAL BRACE

Model Number W0600BLK

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 07/27/2016

Event Type  Injury  

Event Description

Patient claims she developed a contact allergy while wearing the equalizer walker boot which then spread to her other foot and to her hands.Patient made a visit to the doctor and was prescribed steroids and other medications.Patient is no longer wearing the boot.

Event Description

Patient claims she developed a contact allergy while wearing the equalizer walker boot.Patient made a visit to the doctor and was prescribed steroids and other medications.The rash got worse when she started the medication and it then spread to her other foot and hands.She stopped wearing the product and the rash seems to be clearing up.

• Brand Name: EQUALIZER WALKER MEDIUM BLACK
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer (Section G): OSSUR AMERICAS; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5897898
• MDR Text Key: 52840035
• Report Number: 2085446-2016-00005
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: W0600BLK
• Device Catalogue Number: W0600BLK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other