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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD CLR 45MM; POUCH, COLOSTOMY

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CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD CLR 45MM; POUCH, COLOSTOMY Back to Search Results
Model Number 022768
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2014
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 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 it was difficult to remove pouch mass from skin.Weartime is 5 to 6 days.Uses stomahesive powder and protective barrier.User does not want replacements sent.
 
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Brand Name
ACTIVE LIFE PCH STD CLR 45MM
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 Key5155755
MDR Text Key28465181
Report Number9618003-2015-30654
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
Reporter Occupation Patient
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 Expiration Date02/06/2019
Device Model Number022768
Device Lot Number4B03058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2014
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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