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

Model Number 187610

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

Patient Problem No Patient Involvement (2645)

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.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 foreign material was present in the primary pouch.Photos depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

A batch record review was carried out on (b)(6)2018 , for the affected lot number 8a00464.The lot was manufactured following the applicable procedures, all the testing scheme comply with the applicable documentation, the line clearance was executed per standard operating procedures and the results were documented.The material complies with the bill of materials, process instructions, packaging and labeling, design specification, test method, material specification, and other procedures were revised and the results are satisfactory.Sample/photo was not received.Based in the analysis phase conclusions, the issue of black spots on products reported by the customers was attributed to the following probable causes: embedded spots - allowable for chemical manufacturing and control (cmc) material, present in all dressings in varying degrees and evidence of pectin and pentalyn contributing to spots due to change color.High temperature at mixer 06 may cause mass burned.Residues of mass accumulated in the mixer extruder screws reaching to the product as part of the normal mix of mass process.Corrective / preventive actions will be taken for each factor identified and will be covered through corrective action / preventive actions form.No additional information has been provided to date.Should additional information become available a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (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
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8082692
• MDR Text Key: 127880761
• Report Number: 9618003-2018-03086
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/01/2023
• Device Model Number: 187610
• Device Lot Number: 8A00464
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/18/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1