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

Model Number 187957

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional information was requested.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported there were black spots on the dressing.Photos depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

This complaint has been evaluated.A review of the last three (3) product monitoring review's for trends indicated no trends for this issue on this product.The historical complaint data from november 01, 2015 to november 30, 2017 was reviewed as it relates to reports for product icc# (b)(4).A total of one (1) complaint, including this one, was reported.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• MDR Report Key: 7113702
• MDR Text Key: 95062244
• Report Number: 1049092-2017-00088
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 187957
• Device Lot Number: 7B02975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1