MAUDE Adverse Event Report: CONVATEC, INC DUODERM XTHIN DRS 15X15CM; DRESSING,WOUND,OCCLUSIVE

Model Number 187957

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Tissue Breakdown (2681)

Event Date 06/16/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol 2015-001-pro and protocol 2015-002-pro.Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

The end user reported that the duoderm dressing would not would not adhere properly (separated from her skin) on the right hand side so she developed leakage.The end-user indicated she uses duoderm under her 1-piece ostomy appliance.It was reported that the end-user's skin is very sensitive so it became red with a few small areas of bleeding.Use of accessory products was discussed.It was further reported that the end-user applied an unspecified powder and another brand spray and that the skin has nearly cleared up and that only a small amount of irritation remains.

• Brand Name: DUODERM XTHIN DRS 15X15CM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC, INC; 211 american ave; greensboro 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5113584
• MDR Text Key: 27100389
• Report Number: 1049092-2015-30270
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Report Date: 02/27/2014

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?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 10/01/2018
• Device Model Number: 187957
• Device Lot Number: 3K01767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2013
• 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