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

Model Number 125330

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

Patient Problems Rash (2033); Skin Irritation (2076); Fluid Discharge (2686)

Event Date 02/01/2015

Event Type  Injury  

Event Description

It was reported the end user developed an intermittent red, weeping skin under the skin barrier.The rash began under the tape collar and extended both beyond the tape border and under the mass of the skin barrier.The end user presented to his physician and was issued a prescription for clotrimazole.The end user reported no improvement to the rash since that time and has since discontinued use of the clotrimazole.No further information was provided.

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 will be submitted.(b)(6).

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE CUT-TO-FIT PO
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristoba 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4758538
• MDR Text Key: 5890206
• Report Number: 9618003-2015-00024
• 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: 04/29/2015

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: 125330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/07/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 91