MAUDE Adverse Event Report: CONVATEC, INC. NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER; PROTECTOR, OSTOMY 78EXE

Model Number 413182

Device Problems Leak/Splash (1354); Increased Sensitivity (2535)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 06/05/2014

Event Type  Injury  

Event Description

It is reported that a week ago, end-user developed skin irritation; blistering and itching on the abdomen around the stoma related to ostomy use.The end-user saw her ostomy nurse who prescribed an anti-fungal powder which she has been applying since (b)(6) 2014 to the affected site, and the area has improved as a result.It is further reported that her ostomy nurse advised her that the area developed, because she had been on an antibiotics and her wafer had been leaking.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.It is reported that the product was in use for three (3) days before the issue occurred; in addition end-user was advised to change wafer stoma size, and a one inch sized convex product was recommended for use.Lastly, end-user was provided instructions in crusting techniques.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(6) 2014.Note: the actual date of event is unknown, so the date used was the date convatec became aware.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: NATURA 2 PC - DURAHESIVE (DH) CONVEX WAFER
• Type of Device: PROTECTOR, OSTOMY 78EXE
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779239
• MDR Report Key: 3904204
• MDR Text Key: 4515239
• Report Number: 1049092-2014-00251
• Device Sequence Number: 1
• Product Code: EXE
• 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: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413182
• Device Catalogue Number: 413182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2014
• 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