MAUDE Adverse Event Report: DJO, LLC EXOS; SHRT ARM FRACTURE BRACE, BLK, RT, M

Model Number 310-52-1111

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

Patient Problem Numbness (2415)

Event Date 06/12/2018

Event Type  Injury  

Event Description

Complaint received that alledges "on (b)(6) reported decreased sensation on the back of my right thumb.Now over 2 weeks later i am still left with the same altered sensation/numbness.I am still in the brace.".

• Brand Name: EXOS
• Type of Device: SHRT ARM FRACTURE BRACE, BLK, RT, M
• Manufacturer (Section D): DJO, LLC; 1460 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mx
• Manufacturer Contact: william fisher ; 1460 decision street; vista, CA 92081-9663
• MDR Report Key: 7626621
• MDR Text Key: 111944791
• Report Number: 9616086-2018-00015
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 310-52-1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• 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