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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA WATER COOLER

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LIVANOVA WATER COOLER Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Death (1802); Misdiagnosis (2159)
Event Date 07/03/2015
Event Type  Death  
Event Description

My father died of nontuberculous bacteria which is the subject of fda and cdc health warnings last week. He had aortic heart valve replacement in (b)(6) in july 2014. The doctors here in uk had no clue about this bacteria, so he was incorrectly diagnosed with sarcoidosis and given steroids and methotrexate, which caused his rapid decline between (b)(6) 2016. Is there an organization like the fda that should be sending health warnings to doctors in the(b)(6)? he lived a very healthy lifestyle - lots of sport and healthy eating.

 
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Brand NameWATER COOLER
Type of DeviceWATER COOLER
Manufacturer (Section D)
LIVANOVA
MDR Report Key6039447
MDR Text Key57930060
Report NumberMW5065481
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 10/17/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/17/2016 Patient Sequence Number: 1
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