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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH - APS; POUCH, COLOSTOMY

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CONVATEC, INC. ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH - APS; POUCH, COLOSTOMY Back to Search Results
Model Number 416742
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Skin Discoloration (2074)
Event Date 07/18/2013
Event Type  Injury  
Event Description
Per the end user, their skin is red and itchy within 24 hours of when use started.Cleans with soap and water before applying wafer.No further information is available.
 
Manufacturer Narrative
Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Devices listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.
 
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Brand Name
ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE PCH - APS
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC, INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, director
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4147105
MDR Text Key4933770
Report Number1049092-2014-11841
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/19/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/10/2017
Device Model Number416742
Device Lot Number2G00620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/19/2013
Initial Date FDA Received10/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight50
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