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

Model Number 187921

Device Problems Failure To Adhere Or Bond (1031); Device Contamination with Chemical or Other Material (2944)

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.A query was run on december 07, 2017 against lot number 7g02033 for the reported event, and yielded (b)(4) occurrence (s) against the lot.At this time, a detailed investigation or batch review is not required.If additional complaints occur with the batch criteria and same reported event, any subsequent complaints shall be assessed for further investigation.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. (b)(4).

Event Description

It was reported that the product was very thin and that there is a white powder on the top of the dressing which made it very hard to put on the patient.The product was in use for 2 days however, no harm was reported.No photo is available and no further details have been provided.

Manufacturer Narrative

The batch record review showed no irregularities of any kind.No non- conformance was created during the manufacturing process.Microbiological and temperature test were performed and no issue was identified.No sample or photo was available.Based on the investigation results this complaint issue could not be confirmed.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

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

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• MDR Report Key: 7113425
• MDR Text Key: 95737163
• Report Number: 9618003-2017-00056
• 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: foreign,health professional,o
• 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: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: 187921
• Device Lot Number: 7G02033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1