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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC COLODRESS+ PCH CLD STD TAN 38MM; POUCH, COLOSTOMY

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CONVATEC DOM. REPUBLIC COLODRESS+ PCH CLD STD TAN 38MM; POUCH, COLOSTOMY Back to Search Results
Model Number 403816
Device Problem Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Date 06/29/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
The mass adhere very strongly.It's very difficult to remove it.Pain on removal.
 
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Brand Name
COLODRESS+ PCH CLD STD TAN 38MM
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOM. REPUBLIC
inc.: carr. sanchez, km. 18.5
parque industrial, haina
san cristobal, 33102
DR  33102
Manufacturer Contact
jeanette johnson
211 american ave
greensboro, NC 27409
3362973009
MDR Report Key5153708
MDR Text Key28414712
Report Number9618003-2015-30561
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 foreign,health professional
Reporter Occupation Other
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? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/03/2018
Device Model Number403816
Device Lot Number3H02780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2013
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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