MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE PCH STD 38MM; POUCH, COLOSTOMY

Model Number 175783

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

Patient Problem Tissue Damage (2104)

Event Date 03/01/2012

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 reports peristomal wound at 300 oclock measuring 25mmx13mmx.2mm which bleeds at times.No bleeding noted at this time.End user stoma measures approximately 25mm but they are using a 38mm precut opening.She said they use a larger stoma opening to accommodate the fistula to the side of end users stoma.The wound is located where the skin is exposed.They sometimes apply stomahesive powder to the peristomal wound.They have also tried applying aquacel to the peristomal wound but have covered the aquacel with the wafer.Instructed on covering aquacel with a wound dressing such as duoderm extra thin.They sometimes use adhesive remover to end users peristomal skin but could not obtain manufacturer.They use eakin cohesive seals to end users peristomal skin.They use protective barrier wipes but could not obtain manufacturer.They use some type of baby wipes to end users peristomal skin.Instructed many baby wipes have moisturizers in them so they should try to use products that do not contain lotions; moisturizers or creams.End user has had this peristomal wound on and off since (b)(6) 2012.No wear time established.Recommend a flat and flexible 1-piece system.Instructed if area worsens or does not improve to call back for additional instructions.Complainant confirmed lot number is not available.Spoke to end users daughter who is a nurse.

• Brand Name: ACTIVE LIFE PCH STD 38MM
• 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: 5153694
• MDR Text Key: 28412212
• Report Number: 1049092-2015-30559
• 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: health professional,other
• Reporter Occupation: Nurse
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 175783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• 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: Unknown
• Patient Sequence Number: 1