MAUDE Adverse Event Report: ConvaTec Dominican Republic Inc DUODERM; Dressing,Wound,Occlusive

Model Number	187900
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Skin Tears (2516); Tissue Breakdown (2681)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the dressing caused skin damage during removal.She stated that after a short period of wear, the dressing adhered firmly to the skin and, upon removal, resulted in skin tearing.The client discontinued use of the product following the event.Product use and appropriate removal techniques were discussed with the client.No concomitant medications were reported.Outcome was reported as skin torn/ripped.No photo is available at this time.
Additional Manufacturer Narrative
Mdr 9618003-2026-05360 / device 2 of 2.Complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (b)(6).Complainant phone: (b)(6).Complainant country: canada.H6: imdrf medical device problem code - a050901 (adhesive too strong) - as per the information provided by complainant, for the issue dressing adhesive was too abrasive.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.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: DUODERM
• Common Device Name: Dressing,Wound,Occlusive
• Manufacturer (Section D): ConvaTec Dominican Republic Inc; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): ConvaTec Dominican Republic Inc; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; +1(603)247-0255
• MDR Report Key: 50470461
• Report Number: 9618003-2026-05360
• Device Sequence Number: 10157044
• Product Code: NAD
• UDI-Device Identifier: 00768455175048
• UDI-Public: 00768455175048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 187900
• Device Lot Number: 5E03756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown