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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

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THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
Model Number NOT APPLICABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Congestive Heart Failure (1783); Itching Sensation (1943); Swelling (2091)
Event Date 11/10/2010
Event Type  Injury  
Manufacturer Narrative
The system was used for treatment.Since the device could not be ruled out as a possible contributing factor to this event, this case will be reported as a mdr out of an abundance of caution.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device malfunction and no instrument issue was alleged by the customer.The instrument's serial number was not provided; therefore, a device history review could not be conducted.Trends were reviewed for complaint categories, other adverse event: itching, swelling, and other adverse event: congestive heart failure.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: itching, swelling, and congestive heart failure (b)(4).
 
Event Description
The patient reported under the ambassador program that within fifteen minutes of getting off of the instrument, she still had issues with itching.The patient stated that she had a tough time sleeping because of the itching.The patient reported that her feet were beginning to swell and she had a hard time walking.The patient stated that she had congestive heart failure in 2011.The patient reported that she was hospitalized due to her congestive heart failure.The patient stated that she could not say for sure if the congestive heart failure was due to her treatment or due to her underlying condition, but the events did occur after a treatment.The patient's duration of treatment was from nov 2010 to may 2011 (5 months).No product was specified in the complaint.No product was returned for investigation.
 
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Brand Name
CELLEX PHOTOPHERESIS SYSTEM
Type of Device
CELLEX PHOTOPHERESIS SYSTEM
Manufacturer (Section D)
THERAKOS, INC
bedminster NJ
Manufacturer (Section G)
THERAKOS, INC.
10 north high street
suite 300
west chester PA 19380
Manufacturer Contact
megan vernak
1425 us route 206
bedminster, NJ 07921
MDR Report Key6856968
MDR Text Key85744374
Report Number2523595-2017-00169
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/11/2017
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 Nurse
Device Model NumberNOT APPLICABLE
Device Catalogue NumberCELLEX
Device Lot NumberNOT APPLICABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/15/2017
Initial Date FDA Received09/11/2017
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 Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
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