MAUDE Adverse Event Report: DJO, LLC., DJO GLOBAL DONJOY COOL X-ACT ROM; JOINT, KNEE, EXTERNAL BRACE

Catalog Number 11-2151-9

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/29/2015

Event Type  No Answer Provided  

Event Description

Patient was attempting to walk with the brace after the brace was placed and the brace became unlocked, causing the patient to stumble.

• Brand Name: DONJOY COOL X-ACT ROM
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC., DJO GLOBAL; 1430 decision street; vista CA 92081
• MDR Report Key: 4894321
• MDR Text Key: 21545002
• Report Number: 4894321
• Device Sequence Number: 1
• Product Code: IQI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: 11-2151-9
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2015
• Patient Sequence Number: 1