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U.S. Department of Health and Human Services

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

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CONVATEC INC. ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH; POUCH, COLOSTOMY Back to Search Results
Model Number 175779
Device Problems Device Handling Problem (3265); Sharp Edges (4013)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  malfunction  
Manufacturer Narrative
Initial emdr is being re-submitted per request of fda on 03-may-2021.Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 28-sep-2016 on 25-oct-2016, the following information was received: a batch record review found no discrepancies related to the reported complaint.Process checks and quality checks were performed and yielded acceptable results.No additional action is required and this complaint will be closed.The issue will be monitored through the post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 11-nov-2016 (b)(4).
 
Event Description
The end user reported that he tried the convex one-piece approximately one year ago but the opening was not large enough so he cut the opening.After applying the wafer, he noted bleeding from the stoma.He stated he did not see a laceration but surmises that the jagged edges from cutting the opening caused the bleeding.He did not see a physician as the bleeding resolved quickly without treatment once the pouch was removed.
 
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Brand Name
ACTIVELIFE CONVEX ONE-PIECE PRE-CUT POUCH
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 27409
3365424679
MDR Report Key6095589
MDR Text Key248404397
Report Number1049092-2016-00041
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 Other
Type of Report Initial
Report Date 09/15/2016
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 Lay User/Patient
Device Expiration Date10/17/2018
Device Model Number175779
Device Lot Number3K01407
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/15/2016
Initial Date FDA Received11/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age70 YR
Patient SexMale
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