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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number REVACLEAR 400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 05/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
A patient experienced allergic reactions during hemodialysis using a revaclear 400. At the first dialysis session, the patient experienced a small cough. The patient was treated with polaramine. During the second dialysis session, the patient ¿quickly¿ experienced edema of the face. The therapy was immediately stopped and the patient was treated with polaramine. No additional information is available. This emdr is related to the reported first session.
 
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Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen 72379
GM 72379
Manufacturer (Section G)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen
GM
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6597823
MDR Text Key76165023
Report Number9611369-2017-00047
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberREVACLEAR 400
Device Catalogue Number114746
Device Lot NumberASKU
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 Received05/04/2017
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

Patient Treatment Data
Date Received: 05/30/2017 Patient Sequence Number: 1
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