MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA DRAINABLE POUCH 12" OPAQUE; POUCH, COLOSTOMY

Model Number 404016

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

The end user reports several months history of splotchy red areas with itching under skin below stoma; where pouch touches abdomen.Prior to this event; she sought treatment from a healthcare provider and was prescribed nystatin powder which she has been using for three monrths.Due to persistent symptoms; end user is currently being followed by a dermatologist who prescribed a compounded cream mixture of steroid; antibiotic and nystatin cream to apply to the affected area and she was also given a prescription for oral diflucan.The dermatologist recommended her to visit an allergist for allergy testing.The end user was instructed on use of adhesive remover and cavilon no sting spray.

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.Reported to the fda on (b)(6)/2015.

• Brand Name: SUR-FIT NATURA DRAINABLE POUCH 12" OPAQUE
• 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,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4914785
• MDR Text Key: 6013551
• Report Number: 9618003-2015-00034
• 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: 07/02/2015

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: 404016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/13/2015
• 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: NYSTATIN POWDER; FLUCONAZOLE 100MG 1 DAILY; AMLODIPINE FOR BLOOD PRESSURE
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70