MAUDE Adverse Event Report: CONVATEC DOM. REPUBLIC INC ACTIVE LIFE PCH STD CLR CUST; POUCH, COLOSTOMY

Model Number 022771

Device Problem Defective Device (2588)

Patient Problem Tissue Damage (2104)

Event Date 09/17/2014

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

The end user reported that she applied pouch last night but had to remove it immediately to reposition the pouch resulting in a skin abrasion the size of a pencil eraser at 6 o'clock.Cleans with adhesive remover followed by soap.Applies prep.Applies stomahesive paste to center opening of wafer.Wear time 3 days.Product use and skin care instructions provided.

• Brand Name: ACTIVE LIFE PCH STD CLR CUST
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOM. REPUBLIC INC; carr. sanchez, km. 18.5; parque industrial, haina; san cristobal, 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155606
• MDR Text Key: 28449291
• Report Number: 9618003-2015-30621
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 022771
• 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
• 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