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

Model Number 187955

Device Problems Material Disintegration (1177); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: (b)(4).

Event Description

It was reported the dressings were difficult to remove from end user's right leg/ankle wound.He reports the dressing was too sticky to be torn off fully, breaking during removal and remained on the wound tightly in the same shape as the wound bed.He tried to use normal saline to wash the sticky dressing off from the wound but, it didn't work so he tried to clean it with normal saline and wipe it dry every day after the event happened.He is sure that the white exudates adhering to the dressing were still wet around the days before the event date, but the exudates volume did become lesser compared to the first few days.After around two weeks, the wound seems to be healing well, no exudates observed, but the remained dressing is still integrated on the wound site.Photos depicting the reported complaint issue were provided by the complainant.

Event Description

To date no additional patient or event details has been received.

Manufacturer Narrative

Mdr 1049092-2019-00159 / device 3 of 3.A review of the last three product monitoring review's for trends indicated no trends for this issue on this product.The historical complaint data from january 01, 2017 to january 31, 2019 was reviewed as it relates to reports for product international commodity code (icc) 187955.A total of five (5) complaints, including this one, were reported.Photographs were received and reviewed but, not investigated as the manufacturing facility has closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092, manufacturing site: 1049092.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• MDR Report Key: 8355894
• MDR Text Key: 136764930
• Report Number: 1049092-2019-00159
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/13/2022
• Device Model Number: 187955
• Device Lot Number: 7C00736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1