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

Model Number 403326

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Itching Sensation (1943)

Event Date 06/22/2011

Event Type  Injury  

Event Description

Report received indicated that the pt used the dressing at the recommendation of her physician on a small superficial burn on her left wrist.Within one day she developed itching; the second day the itching was increased.The pt removed the dressing on the third day and discovered small blisters surrounding the wound.The burn had improved.The blisters did open and drain.The pt applied a topical cortisone cream and the area has improved since then.

Manufacturer Narrative

A review of the batch record and a retain eval could not be performed without a valid lot number.A 12 month review of complaint listings for blister/breakdown under product, (b)(4) found that this was the only case reported.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE-MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: OCCLUSIIVE WOUND DRESSINGS
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew waleniak, dir, post mark ; 211 american ave.; greensboro, NC 27409 ; 9083772993
• MDR Report Key: 4020733
• MDR Text Key: 4707507
• Report Number: 1049092-2014-10107
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/28/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 403326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2011
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118