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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER Back to Search Results
Model Number ELI-21H-PO-GJ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Dyspnea (1816); Increased Sensitivity (2065)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
Customer discarded the actual used device, unused samples from same lot were returned for evaluation.
 
Event Description
Approximately 5 and 15 minutes after intiation of dialysis treatment, patient experienced allergic reaction to the dialyzer membrane. Patient experienced dyspnea and intense abdominal pain. Treatment was interrupted, patient was disconnected and antihistamine was administered. Patient's symptoms disappeared, new dialysis connection was set up with another dialyzer. No further information was provided.
 
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Brand NameNIPRO ELISIO-H DIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer (Section G)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer Contact
michelle tejada
3150 nw 107 avenue
miami, fl 
5997174234
MDR Report Key7300248
MDR Text Key191730093
Report Number9610987-2018-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Model NumberELI-21H-PO-GJ
Device Lot Number17G13C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/13/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/27/2018 Patient Sequence Number: 1
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