MAUDE Adverse Event Report: CONVATEC LIMITED DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING; OCCLUSIVE WOUND DRESSINGS

Model Number 187659

Device Problem Human-Device Interface Problem (2949)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Report received indicated the patient experienced blistering and skin breakdown with pain under dressing.Report also noted the patient experienced the adverse reaction over a period of four days due to a possible reaction to a film dressing product.The product was discontinued and the hydrocolloid dressing was applied.Patient is under care of home health nurse and has advised patient to discontinue use of duoderm and to use protective barrier wipe on skin.Patient outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 16, 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.A lot number could not be obtained; therefore, a review of the batch record data could not be performed without a valid lot number.A review of the complaint listing for the previous 12 months for this product icc code indicates that there were 2 complaint issues for the blister/breakdown under product at the time of this analysis.Convatec will continue to monitor these issues and process accordingly.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: OCCLUSIVE WOUND DRESSINGS
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4061108
• MDR Text Key: 4864239
• Report Number: 1000317571-2014-10713
• Device Sequence Number: 1
• Product Code: MGP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973632
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 187659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 64