• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GAMBRO RENAL PRODUCTS REVACLEAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 110633
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 05/02/2017
Event Type  Injury  
Manufacturer Narrative
N/a.
 
Event Description
A patient was to undergo hemodialysis using a revaclear dialyzer. Before treatment the patient was "stable and asymptomatic. " the patient experienced swelling of the lips approximately thirty minutes into treatment. The treatment was ended with blood returned to the patient. Benadryl and epinephrine were given to the patient intramuscularly. The reporter stated that the symptoms abated ¿immediately¿ following treatment. Emergency services were called and the patient was taken to the emergency room. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVACLEAR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS
1101 jeter avenue
opelika AL
Manufacturer (Section G)
GAMBRO RENAL PRODUCTS
1101 jeter avenue
opelika AL 36801
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6594883
MDR Text Key76124007
Report Number3006552611-2017-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072232
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 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number110633
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 Received05/02/2017
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: 05/26/2017 Patient Sequence Number: 1
-
-