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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED EASI V FOAM NARROW; DEVICE, INTRAVASCULAR CATHETER SECUREMENT
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CONVATEC LIMITED EASI V FOAM NARROW; DEVICE, INTRAVASCULAR CATHETER SECUREMENT Back to Search Results
Model Number 417109
Device Problems Loss of or Failure to Bond (1068); Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2013
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21 cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
It was reported that the foam is not strong enough so the cannula-fixation peels off easily (it peels off after few hours).The hospital reported the complaint in different boxes belonging to different lots number.
 
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Brand Name
EASI V FOAM NARROW
Type of Device
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Manufacturer (Section D)
CONVATEC LIMITED
first ave
deeside industrial park
deeside, flintshire CH52N U
UK  CH52NU
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5205025
MDR Text Key30833761
Report Number1000317571-2015-31389
Device Sequence Number1
Product Code KMK
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number417109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received11/05/2015
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 Unknown
Patient Sequence Number1
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