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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC COLODRESS+ PCH CLD STD TAN 25MM; POUCH, COLOSTOMY
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CONVATEC DOMINICAN REPUBLIC, INC COLODRESS+ PCH CLD STD TAN 25MM; POUCH, COLOSTOMY Back to Search Results
Model Number 403814
Device Problems Difficult to Remove (1528); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2014
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 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
Complainant states: the mass adheres very strongly its difficult to remove.
 
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Brand Name
COLODRESS+ PCH CLD STD TAN 25MM
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
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5157680
MDR Text Key28564559
Report Number9618003-2015-30502
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number403814
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/27/2014
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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