MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING; NOT APPLICABLE

Model Number 187921

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

This initial report is being submitted as the initial and supplemental mdr, mfr report# 9618003-2018-00067 on march 28, 2018 and may 11, 2018, due to error for report identifier.Resubmitting the report with a new mdr mfr number with the same data as this is not a duplicated report.No complainant street address, state/province/postal code or phone number provided.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.(b)(4).

Event Description

It was reported the pouches were not completed sealed.No photos were provided.

Event Description

It was reported the pouches were not completed sealed.No photos were provided.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Based on the investigation findings through evaluation of the batch records documentation, process observation and processes replication, the investigation concluded that the most likely explanation for the open/incorrect seal was inconsistency of the labeler machine in placing the japanese labels prior to sealing the chevron pouches.Quality inspections were properly performed as per the evidences provided from the batch record.However, the peel off test is a destructive test so not all units al inspected.Ca - validate alternative manual process to place japanese labels in the doyen machine.Ca - disable doyen japanese labeler machine once the manual process is validated.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: NOT APPLICABLE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• MDR Report Key: 11671116
• MDR Text Key: 247924497
• Report Number: 9618003-2018-00257
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: 187921
• Device Lot Number: 7H05089
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1