MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC - DURAHESIVE WAFER; PROTECTOR, OSTOMY

Model Number 413155

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

Patient Problems Erythema (1840); Rash (2033); Skin Discoloration (2074)

Event Date 05/01/2013

Event Type  Injury  

Event Description

End-user reported that approximately seven (7) months ago skin at the right lower quadrant presented with a red, splotchy, non-open, itchy rash located in scattered areas under wafer's mass.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.It is reported that end-user has been washing skin with alcohol then dries and applies triamcinolone acetate 1 percent cream to skin by rubbing product on skin, then applies wafer.End-user was provided the following skincare instructions: cleanse with water then dry skin and to use antifungal powder, and allow to dry then apply wafer.It is reported that end-user will contact physician for antifungal powder and was advised to discontinue use of steroid cream on skin.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.

• Brand Name: NATURA 2 PC - DURAHESIVE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, associate dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3597053
• MDR Text Key: 4090644
• Report Number: 1049092-2014-00037
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• 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: 12/23/2013

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: 413155
• Device Catalogue Number: 413155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/21/2014
• 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 Weight: 64