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

Model Number 187957

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-17392 / device 1 of 7. (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 there was a black spot found on the dressing. The product was not used. Photos depicting the reported complaint issue were provided by the complainant.

Event Description

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

Manufacturer Narrative

H. 4: corrected the manufacturing date from 07/20/2019 to 07/18/2019. A review of batch records 9g03068 was performed by compliance engineer id 6053 on 08/09/2020. Lot: 9g03068 was manufactured on 07/18/2019, in the bodolay line with a total of (b)(4) each (ea). All the components utilized were correct per bill of materials (bom), under international commodity code (icc) 187957, system application product (sap) material identification: 1704769 and manufacturing order: 1487425. The testing results were found satisfactory and the crew requirements and responsibilities, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instructions. In addition, the dressing bulk batch records: 9g03076 and 9g02321 were reviewed, and all test results were satisfactory, the process followed was found to be in accordance with process instructions and no irregularities or non-conformances related to this issue were found in the documentation. Therefore, no discrepancy related to this issue were found in the revised documentation. There are several photographs associated with this case and in these, the reported defect can be seen. No unused return sample was expected. Based in the analysis phase conclusions, the issue of black spots on products reported by the customers was attributed to the following probable causes: 1. Material: embedded spots: allowable for chemical manufacturing & control (cmc) material, present in all dressings in varying degrees and evidence of pectin and pentalyn contributing to spots due to change color. 2. Machine: high temperature at mixer 06 may cause mass burned. 3. Method: residues of mass accumulated in the mixer extruder screws reaching to the product as part of the normal mix of mass process. Actions were taken for each factor identified under a corrective / preventive action (capa). The investigation associated with non-conformance has been approved and is complete. This complaint will be closed. 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. Fda registration number: reporting site: 1049092. Manufacturing site: 9618003.

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9536286
• Report Number: 9618003-2019-17392
• 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

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 9G03068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No