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

Model Number 175765

Device Problem Difficult to Remove (1528)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.A detailed investigation or batch review cannot be conducted due to a lot number or product evaluation sample being unavailable.Therefore, this evaluation will be closed and monitored through our 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

An end user reported small scattered areas of irritated skin around the stoma under the mass.Additionally, the end user reported that within one (1) day of wear time the mass part of the pouch is difficult to remove, which she feels caused the irritation.

• 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: 5451024
• MDR Text Key: 38701482
• Report Number: 9618003-2016-00008
• 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: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2016
• 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: MEDICATION FOR BLOOD PRESSURE (NOT SPECIFIED)
• Patient Age: 92 YR
• Patient Weight: 45