MAUDE Adverse Event Report: OSSUR CTI KNEE BRACE; ORTHOSIS, LIMB BRACE

Model Number B-7095000025

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

Patient Problem Sprain (2083)

Event Date 07/10/2015

Event Type  Injury  

Event Description

Patient was wearing one of our braces while playing soccer.While running on the soccer field she tore her acl tendon.

Manufacturer Narrative

We are working to obtain further information from the patient related to the product in use and the incident details.Limited information available at time of report.

Event Description

Patient was wearing one of our braces while playing soccer.While running on the soccer field she tore her acl tendon.

• Brand Name: CTI KNEE BRACE
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): OSSUR; blvd hector teran teran 2102; edificio #1, col. de canon del; tijuana, baja california 2102 ; MX 2102
• Manufacturer (Section G): OSSUR; 27051 towne centre; foothill ranch CA 92610
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4961206
• MDR Text Key: 6190680
• Report Number: 3008523132-2015-00002
• 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: Consumer,consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-7095000025
• Device Catalogue Number: B-7095000025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention