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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE
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GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE Back to Search Results
Catalog Number 101025
Device Problem Insufficient Information (3190)
Patient Problem Headache (1880)
Event Date 01/21/2015
Event Type  Injury  
Event Description
A pt who began dialysis treatments less than one year ago frequently experienced headaches approximately 2-3 hours into the treatment but not every treatment.The pt has a history of hypertension and at times there is a correlation with the headache and hypertension.Immediately following a dialysis treatment the pt was admitted to the hospital and treated for pulmonary edema, diabetes and headache.The pt was hospitalized for several days and the cause of the headaches was not determined.The pt has continued dialysis with a different dialyzer and although the headaches have improved, he still occasionally experiences headaches during dialysis.Neither the phoenix machine nor the disposables used at the time of this event were inspected.Mfr ref #8030638-2015-00003.
 
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Brand Name
CARTRIDGE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS S.A. DE C.V.
tijuana
MX 
MDR Report Key4649521
MDR Text Key18543447
Report Number2087532-2015-00022
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number101025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date02/25/2015
Event Location Outpatient Treatment Facility
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REVACLEAR; BICART; PHOENIX
Patient Outcome(s) Hospitalization;
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