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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC. THERAKOS; CELLEX
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MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC. THERAKOS; CELLEX Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Chest Pain (1776); Dyspnea (1816)
Event Date 12/30/2017
Event Type  Injury  
Event Description
A (b)(6) male with hx of hodgkin's disease state iiia (completed chemotherapy (b)(6) 2012), therapy related aml m6 s/p stem cell transplant (b)(6) 2014 c/b gvhd, hfpef (lvef 45 percent) who presents to ed with dyspnea and right-sided chest pain.Pt reports doe for last month to 1/2 block, acutely worsening in am on (b)(6) 2017 to sob at rest.More pronounced with movement.Associated with dry cough.Also notes r-sided chest pain, worsened with inspiration or coughing, moving right arm.Patient has been receiving extracorporeal photopheresis on therakos cellex machine.Last procedure prior to this event was on (b)(6) 2017.Has been on twice a week, every other week ecp procedure schedule since (b)(6) 2016.
 
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Brand Name
THERAKOS
Type of Device
CELLEX
Manufacturer (Section D)
MALLINCKRODT PHARMACEUTICALS/ THERAKOS, INC.
westchester PA
MDR Report Key7250938
MDR Text Key99584992
Report NumberMW5075114
Device Sequence Number1
Product Code LNR
UDI-Device Identifier3010885864
UDI-Public3010885864
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/06/2018
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 Received02/07/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age61 YR
Patient Weight96
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