MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS; CELLEX

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

Patient Problems Occlusion (1984); Pulmonary Infarction (2021); Thrombosis (2100); Thrombus (2101)

Event Date 03/19/2018

Event Type  Injury  

Event Description

Patient developed bilateral lower extremity dvt following photopheresis therapy.She also had a lll pulmonary infarct with suspicion for pe.Patient had received a total of 8 treatments prior to this finding.Occlusive thrombus of right femoral vein and popliteal vein.Occlusive thrombus left external iliac vein into the common femoral vein.

• Brand Name: THERAKOS
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC. ; raritan NJ 08869
• MDR Report Key: 7384682
• MDR Text Key: 104135023
• Report Number: MW5076233
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2018

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 79