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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISITAN60/70MM; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISITAN60/70MM; POUCH, COLOSTOMY Back to Search Results
Model Number 416719
Device Problems Difficult to Remove (1528); Sticking (1597)
Patient Problem Skin Irritation (2076)
Event Date 05/17/2012
Event Type  Injury  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).(b)(4).
 
Event Description
Complainant reports "adhesive is too aggressive and ,when the pouch is removed, leaves reddened skin.".
 
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Brand Name
ESTEEM PCH DRNWFINVISITAN60/70MM
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC, INC
18.5 parque industrial
haina, san cristobal 33102
DR  33102
Manufacturer Contact
jeanette johnson
7900 triad center drive
greensboro, NC 27409
3365424681
MDR Report Key5289393
MDR Text Key33275775
Report Number9618003-2015-40073
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeIT
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 11/06/2015
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? Yes
Device Operator No Information
Device Expiration Date09/30/2016
Device Model Number416719
Device Lot Number1J02837
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/06/2015
Initial Date FDA Received12/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2011
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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