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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC, INC ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE; POUCH, COLOSTOMY

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CONVATEC, INC ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE; POUCH, COLOSTOMY Back to Search Results
Model Number 175780
Device Problem Leak/Splash (1354)
Patient Problem Hyperplasia (1906)
Event Type  Injury  
Event Description
The end user developed hyperplasia or peristomal skin as a result of leakage from her wafer.An ostomy nurse started removal of the hyperplasia by using silver nitrate.It was also noted there was a small amount of bleeding from removing the hyperplasia.Advised to use stomahesive powder and barrier wipes to crust weeping hyperplasia.
 
Manufacturer Narrative
Based on the available info, this event is deemed to be a serious injury.No add'l pt/event details have been provided to date.Should add'l info become available a follow up report will be submitted.
 
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Brand Name
ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC, INC
211 american ave.
greensboro NC 27409
Manufacturer Contact
matthew walenciak, interim associ
211 american ave.
greensboro, NC 27409
9083779293
MDR Report Key4395757
MDR Text Key5430362
Report Number1049092-2015-00008
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/18/2014
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? No
Device Operator Other
Device Model Number175780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/18/2014
Initial Date FDA Received01/07/2015
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age93 YR
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