MAUDE Adverse Event Report: OSSUR AMERICAS GAMEDAY ANKLE BRACE WITH FIGURE 8 STRAP; JOINT, ANKLE, EXTERNAL BRACE

Model Number HC000697

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Rash (2033); Scarring (2061); Skin Discoloration (2074); Skin Irritation (2076)

Event Date 08/01/2016

Event Type  Injury  

Event Description

Patient wearing the gameday ankle brace with the figure-8 strap off and on for 1-2 weeks developed skin irritation and a rash right above her ankle.She tried wearing the product with and without a sock and still felt skin irritation.Patient visited a dermatologist on (b)(6) 2016 and was provided with a prescription to use for 4 weeks.Patient did not have the name of the prescription.The rash caused a scar which will require future bleaching treatments with the dermatologist.

Event Description

Patient wearing the gameday ankle brace with the figure-8 strap off and on for 1-2 weeks developed skin irritation and a rash right above her ankle.She tried wearing the product with and without a sock and still felt skin irritation.Patient visited a dermatologist on (b)(6) 2016 and was provided with a prescription to use for 4 weeks.Patient did not have the name of the prescription.The rash caused a scar which will require future bleaching treatments with the dermatologist.

• Brand Name: GAMEDAY ANKLE BRACE WITH FIGURE 8 STRAP
• 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 ; 9492757557
• MDR Report Key: 5898025
• MDR Text Key: 52839252
• Report Number: 2085446-2016-00006
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HC000697
• Device Catalogue Number: HC000697
• Device Lot Number: 510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• 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
• Patient Age: 43 YR