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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 CUST; POUCH, COLOSTOMY
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CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD CLR CUST; POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Difficult to Remove (1528)
Patient Problem Tissue Damage (2104)
Event Date 09/26/2014
Event Type  Injury  
Manufacturer Narrative
Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
 
Event Description
End-user complained skin stripped on pouch removal.
 
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Brand Name
ACTIVE LIFE PCH STD CLR CUST
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
7900 triad center drive
greensboro, NC 27409
3365424681
MDR Report Key5288962
MDR Text Key33265237
Report Number9618003-2015-40086
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial
Report Date 11/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/18/2016
Device Model Number022771
Device Lot Number1K 01736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2011
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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