MAUDE Adverse Event Report: CONVATEC INC. STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER; CEMENT, STOMAL APPLIANCE, OSTOMY

Model Number 183910

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 11/01/2012

Event Type  Injury  

Event Description

The patient reports an allergy to the product.The patient reported her skin became itchy and red after using the protective paste.The patient also indicated she uses multiple product brands and change the products frequently due to the location of the stoma.The patient sought medical attention from her local physician, however, details regarding the outcome of that appointment were not provided.

Manufacturer Narrative

Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device (s) listed in this report is (are) used for treatment, no diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.

• Brand Name: STOMAHESIVE PASTE PROTECTIVE SKIN BARRIER
• Type of Device: CEMENT, STOMAL APPLIANCE, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4101798
• MDR Text Key: 4835172
• Report Number: 1049092-2014-11081
• Device Sequence Number: 1
• Product Code: EZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/13/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 183910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2012
• 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