MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISICLR60/70MM; POUCH, COLOSTOMY

Model Number 416718

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 09/11/2012

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complainant reports "placed product on (b)(6) 2012, and today when removed, product noted red-raised, hive like rash under wafer mass and all over entire chest and body and back.Reports itching.Has not changed routine in skin care.Reports cleansing with dove soap and water, after adhesive remover, and pats dry.Apples stomahesive paste then appliance.Discontinuing use of product and contacting doctor for antihistamine.".

• Brand Name: ESTEEM PCH DRNWFINVISICLR60/70MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5289473
• MDR Text Key: 33276832
• Report Number: 9618003-2015-40081
• 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: Patient
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• 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: FLUOXATINE
• Patient Weight: 88