MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL AG+/AAA SURGICAL; DRESSING, WOUND, DRUG

Model Number	422607
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patinet city: (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.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
Event or Problem Description
It was reported by a clinical nurse to our company representative that the issue had occurred with patient who had surgery from an orthopedic surgeon at the hospital.The dressing was removed via taffy pull technique in clinic and a large amount of patches of adhesive residue remained adhered on the skin.Furthermore, it was reported that the dressing was difficult to remove.The patient had to go home and shower to remove residue.Skin was prepped with chlorhexidine gluconate (chg) and it was left to dry completely before applying dressing, in the operating room (or).Dressing was not applied with tension and not stretched.The surgeons were aware of "taffy pull" method and used an adhesive releaser.The patient had to go home and shower to remove residue.The product did not tear her skin.No injuries were reported.No photo was available at this time.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary photograph, video and/or physical sample evaluation: no photographs were received for this issue for evaluation in accordance with work instructions (wi).No samples were available for this complaint, and therefore it was not possible to confirm the complaint.Batch record revision results: lot 4j01326 was manufactured on 10/oct/2024, in surgical cover dressing (scd) packaging line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 30/may/2025, 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 identification (id) and manufacturing order (b)(4).Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.The defect reported by the customer could occur during the process performed in the extrusion, lamination & cutting process (elc) #10 & roping durahesive mix manufacturing lines.For this reason, a detailed batch record review was performed of the subassembly lot(s) manufactured in this line.The subassembly lots 4h02720, 4j01329, 4h01968, 4h05746, 4h01967, 4j00841 & 4j01432, were manufactured in the elc#10 manufacturing line.The complaint investigator performed a batch record review on 30/may/2025 and it was confirmed that the applicable procedures were followed, the components for assembly were correct as per bom and the equipment settings were the applicable ones.The batch record review supports that there were no discrepancies related to the issue reported.The subassembly lots 4h01294, 4h05034, 4h05035, 4j00555, 4h01293, 4h02332, 4j01807, 4h01686, 4g05286, 4h05033 & 4j00554, were manufactured in the roping durahesive mix manufacturing line.The complaint investigator performed a batch record review on 30/may/2025 and it was confirmed that the applicable procedures were followed, the components for assembly were correct as per bom and the equipment settings were the applicable ones.The batch record review supports that there were no discrepancies related to the issue reported.Historical nonconformance review: on 30/may/2025, complaints investigator ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction "adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove)" defect for the lot number 4j01326 and as result, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lot.Subassembly lots were also reviewed in order to look for any in process nonconformance/capa (s) associated with the defect and as a result, no nonconformance/capa (s) for this malfunction were generated during the manufacturing process of these lots.Current quality controls: based on the process instruction for the elc#10 line, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm) m2 "hydrocolloid rolling ball tack test": · acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been (b)(4) defective parts confirmed to date from a lot size (b)(4) products.This represents a defect rate of only (b)(4), which is well within an appropriate acceptable quality level (aql) for this defect which should be (b)(4) based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an aql of (b)(4).To date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: as no photographs or samples were available for this complaint issue, it was not possible to raise an investigation for the issue reported.A batch record review was completed and showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: AQUACEL AG+/AAA SURGICAL
• Common Device Name: DRESSING, WOUND, DRUG
• 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; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3367062840
• MDR Report Key: 22076303
• Report Number: 9618003-2025-01774
• Device Sequence Number: 18516749
• Product Code: FRO
• UDI-Device Identifier: 00768455169566
• UDI-Public: 00768455169566
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: Health Professional
• Device Model Number: 422607
• Device Lot Number: 4J01326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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