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

Model Number 412002

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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 matter was present in the sealing part of the peel pouch in 45 dressings.Photos depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi).H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: lot 8a06770 was manufactured on 02/02/2018, in bodolay line, with a total of (b)(4) ea.Compliance engineer performed a batch record review on 09/30/2020, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material id (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there is a photograph associated with this case and in it, the defect reported by the customer can be seen.No unused return sample has been received for this complaint.Conclusion summary of the related event: based on the results of the preliminary investigation, the batch record reviews were performed, and no discrepancies were found.No harm was reported from any of the complainants.A revision of the improvements made to the process was performed, and actions have been implemented for some of the defect types reported.In addition, a retraining in the tm-002 will be given to the quality personnel of the bodolay line, in order to reinforce the correct execution of the method 7, which indicates the outlines that the visual testing required to ensure that the primary packaging, secondary packaging and package printing are free from nonconformities by visual means.Furthermore, an ncr search conducted shows that no adverse trend was identified from january 2018 to august 2020 for this failure mode.The investigation associated with related event has been approved and is complete.No additional action is required, and 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.

Event Description

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

• 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
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 8159950
• MDR Text Key: 130334041
• Report Number: 9618003-2018-04053
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 412002
• Device Lot Number: 8A06770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1