MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE ONE-PIECE DRAINABLE POUCH WITH DUR; POUCH, COLOSTOMY

Model Number 400598

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

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Rash (2033); Burning Sensation (2146)

Event Type  Injury  

Event Description

It was reported the end user developed an itchy, red rash, approximately 64 millimeters in size, under the skin barrier months ago.In addition, she noted a reddened area at the mucocutaneous juncture that occasionally caused pain and a burning sensation.She sought treatment from a physician and was prescribed an anti-fungal powder (unknown name) to apply to the mucocutaneous juncture.The patient has treated the rest of the area with an over-the-counter ointment (a and d ointment).No further patient complications were reported as a result of this event.

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.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE POUCH WITH DUR
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo; san cristobal 3, s.a. haina ; DR
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4955906
• MDR Text Key: 6192655
• Report Number: 9618003-2015-00044
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 400598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2015
• 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: STOMAHESIVE PASTE; NEXIUM; A AND D OINTMENT; NORVASC; CLOPIDOGREL; PROTECTIVE BARRIER WIPE; LAXATIVE; SENNA; POTASSIUM; ARMOUR THYROID; BABY ASPIRIN; LIPITOR; HYDRALAZINE; ATENOLOL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 54