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

Model Number 175779

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

End user reports 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 states 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 avenue, suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5983090
• MDR Text Key: 55806447
• Report Number: 1049092-2016-00411
• 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: 09/28/2016
• 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