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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC ACTIVE LIFE PCH DRN F STDCLR19MM; POUCH, COLOSTOMY
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CONVATEC DOM. REPUBLIC ACTIVE LIFE PCH DRN F STDCLR19MM; POUCH, COLOSTOMY Back to Search Results
Model Number 400394
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2014
Event Type  malfunction  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.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
It was reported a leakage due to sharp cutting edge at the seam.
 
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Brand Name
ACTIVE LIFE PCH DRN F STDCLR19MM
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 Key5135832
MDR Text Key27807248
Report Number9618003-2015-30543
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Report Date 02/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number400394
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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