MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE; POUCH, COLOSTOMY 78 EZQ

Model Number 022766

Device Problem Insufficient Information (3190)

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

Event Date 10/16/2014

Event Type  Injury  

Event Description

It is reported that on or about (b)(6) 2014, the end-user developed a circumferential red rash like area under tape collar and mass which extends outward approximately 76 mm and is also present on her right anterior thigh where the skin barrier comes in contact with her skin.She does experience itching in the area.

Manufacturer Narrative

On an unk date, the end-user saw her ostomy nurse who recommended nystatin powder and fluconazole.She was seen by a dermatologist who prescribed topical application of fluocinonide cream to the red rash like area.The end-user is applying this cream to the rash beyond the barrier and her thigh but not under the barrier.The dermatologist performed an allergen patch test and the end-user had a plus one (1) reaction under the mass and plus two (2) reaction under the white tape collar.It was also determined the end-user was allergic to isothiazolinone.Based on the available info, this event is deemed to be a serious injury.No further info was available at the time of the report.A return sample for evaluation is not expected.Should additional info become available, a follow-up report will be submitted.The end-user confirmed that a lot number is not available.Note: the date of the event is unk, so the date used was the date convatec became aware.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY 78 EZQ
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4203262
• MDR Text Key: 5146437
• Report Number: 9618003-2014-00092
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022766
• Device Catalogue Number: 022766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109