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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEO 90 INFUSION SET CLEO 90 INFUSION SET 24" 9MM

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CLEO 90 INFUSION SET CLEO 90 INFUSION SET 24" 9MM Back to Search Results
Lot Number 76X033
Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2016
Event Type  malfunction  
Event Description
Pt is user of infusion sets having used multiple different brands (engineered by trade). He has trouble with his product - states the surface area of the adhesive is insufficient and he cannot keep his needle in his skin. Dose or amount: change every 72 hours. Reason for use: diabetes.
 
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Brand NameCLEO 90 INFUSION SET
Type of DeviceCLEO 90 INFUSION SET 24" 9MM
MDR Report Key5658722
MDR Text Key45376372
Report NumberMW5062290
Device Sequence Number1
Product Code FPA
UDI-Device Identifier61058602839
UDI-Public61058602839
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2017
Device Lot Number76X033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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

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