MAUDE Adverse Event Report: OSSUR CTI CUSTOM STANDARD RIGHT; ORTHOSIS, LIMB BRACE

Model Number B-116500010

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

Patient Problem Laceration(s) (1946)

Event Date 03/30/2015

Event Type  Injury  

Event Description

Patient was playing basketball while wearing a cti custom knee brace.Another player went to dive for the ball and cut his hand open on the brace causing 7 stitches.The patient was unable to find any sharp pieces on the brace to identify where or how the player cut his hand.

• Brand Name: CTI CUSTOM STANDARD RIGHT
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): OSSUR; MX
• Manufacturer Contact: karen montes ; 27051 towne centre; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4743025
• MDR Text Key: 5704170
• Report Number: 3008523132-2015-00001
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B-116500010
• Device Catalogue Number: B-116500010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2015
• 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