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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH REVACLEAR 300 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH REVACLEAR 300 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number REVACLEAR 300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Numbness (2415)
Event Date 05/04/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
A patient experienced itchiness and numbness in/outside their mouth after 2. 0 hours of treatment using a revaclear 300 dialyzer. Treatment was ended with blood returned to the patient. The patient was given benadryl and the symptoms resolved within 20 minutes. Therapy was not continued following the event. No additional information is available.
 
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Brand NameREVACLEAR 300
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 Key6598593
MDR Text Key76211211
Report Number9611369-2017-00049
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Expiration Date02/09/2020
Device Model NumberREVACLEAR 300
Device Catalogue Number114745
Device Lot Number7-9220-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/30/2017
Distributor Facility Aware Date05/04/2017
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer05/30/2017
Date Manufacturer Received05/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2017
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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