MAUDE Adverse Event Report: CONVATEC, INC. ACTIVE LIFE PCH SM CLR 32MM; POUCH, COLOSTOMY

Model Number 175781

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 02/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Customer's wife calls to report one blister on end user's skin underlying mass above the stoma.Usual weartime is 5 days.He has had this blister off and on for several years.This heals spontaneously.Instructed in appropriate skin.Instructed in crusting using sting free sensi care protective barrier spray and wipe.Instructed on (b)(6) 2014 by er physician to hold pressure on bleeding blister.Bleeding stopped on (b)(6) 2014.He stopped taking blood thinner xarelto for 2 days as recommended by physician and restarted this on (b)(6) 2014.No bleeding is reported today.

• Brand Name: ACTIVE LIFE PCH SM CLR 32MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5150499
• MDR Text Key: 28293405
• Report Number: 1049092-2015-30425
• 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: Patient Family Member or Friend
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/26/2017
• Device Model Number: 175781
• Device Lot Number: 2F02732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2015
• 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 Outcome(s): Required Intervention
• Patient Weight: 83