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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500318N
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 12/14/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a patient had a reaction to a fresenius dialyzer during hemodialysis (hd) treatment. Additional patient, event, and treatment information was requested, but was not provided.
 
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Brand NameOPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key8199892
MDR Text Key131514162
Report Number1713747-2018-00503
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0500318N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1
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