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

Model Number 175764

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

Complainant reports that the barrier disintegrated on the skin when it was time to remove, making it difficult to remove and causing skin irritation.The complainant went on to report that they treated the redness was treated with over the counter (b)(4) lotion.It was further reported that no further medical treatment was required.

• Brand Name: ACTIVELIFE® ONE-PIECE PRE-CUT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5949267
• MDR Text Key: 54668266
• Report Number: 9618003-2016-00046
• 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: other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 175764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• 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
• Treatment: ADHESIVE REMOVER (NAME NOT PROVIDED); SAFE N SIMPLE SKIN CLEANSER; SENICARE STING FREE BARRIER WIPES; STOMAHESIVE POWDER (NAME NOT PROVIDED)
• Patient Weight: 39