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

Model Number 175772

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 01/01/2015

Event Type  Injury  

Event Description

The end user reports an itchy, red rash like area under the pouch film which started months ago.She sought treatment from her doctor who prescribed clotrimazole cream and ketoconazole cream for the affected area.End user was advised to try a closed ended plus pouch and to call back for additional instructions if area worsens or does not improve.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report wil be submitted.

• Brand Name: ACTIVIELIFE ONE-PIECE PRE-CUT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC , INC; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak, assoc. dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4826456
• MDR Text Key: 5841770
• Report Number: 9618003-2015-00028
• 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: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 06/08/2015
• 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
• Treatment: MEDICATIONS: COUMADIN,; CLOTRIMAZOLE CREAM,; KETOCONAZOLE CREAM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 47