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

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.

• 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 Key: 6095589
• MDR Text Key: 248404397
• Report Number: 1049092-2016-00041
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2018
• Device Model Number: 175779
• Device Lot Number: 3K01407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male