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

Model Number 187957

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-08644 / device 1 of 2.(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 is black dust inside and outside the package.Photos depicting the reported complaint issue were provided by the complainant.The product was not used by the patient.

Event Description

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

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Photograph, video and/or physical sample evaluation: there are photograph(s) associated with this case and in these, 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 (b)(6) 2018 to (b)(6) 2020 for this failure mode.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: 9451917
• MDR Text Key: 177577089
• Report Number: 9618003-2019-08644
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 9F00417
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1