MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

Model Number 187959

Device Problems Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2018

Event Type  malfunction  

Manufacturer Narrative

Common device name ¿ dressing, wound, occlusive.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Per the information for use (ifu), the maximum recommended wear time for this product is up to seven (7) days.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 after application once on patient, the dressing is difficult to remove from the patient.It was further reported that the product was used for ten (10) days.No harm was reported.

Event Description

Additional information was provided confirming that the product was used for fourteen (14) days, and not ten (10) days that was initially reported.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8027724
• MDR Text Key: 125768333
• Report Number: 9618003-2018-03116
• 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,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2020
• Device Model Number: 187959
• Device Lot Number: 187959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1