MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE ONE-PIECE DRAINABLE CUT-TO-FIT; POUCH, COLOSTOMY

Model Number 125330

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The end user reported he developed an abcess to the peristomal skin and, as a result, has experienced decreased wear time with his one-piece colostomy pouch.The end user has kept the abcess protected by applying gauze prior to the application of this colostomy pouch.The end user was referred to his physician for treatment.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however, no additional pt/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE CUT-TO-FIT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km 18.5; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4317463
• MDR Text Key: 5214589
• Report Number: 9618003-2014-00099
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 125330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2014
• 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