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

Model Number	422606
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece of hair found inside the package of the dressing.A new package was opened.The product was not used.No photo is available at this time.
Additional Manufacturer Narrative
E1: (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
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.Based on the available information, this event is deemed to be a reportable malfunction.Batch record review: lot 5c04810 was manufactured on 24/mar/2025, in scd packaging line, with a total of (b)(4) market units (mkus).The complaints engineer performed a batch record review on 11/feb/2026, 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) 1728533 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 was found within the documentation.The reported malfunction could be generated during the manufacturing process of the final line, therefore no further batch record review of the subassembly lots was required.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Historical complaints review: on 11/feb/2026, complaints engineer ran a query in database in order to verify the complaints reported for the 5c04810 lot for the malfunction ¿foreign matter (e.G.Hairs, insects) within primary pack (sterile products)¿ defect and no additional complaints were identified.Historical nonconformance review: on 11/feb/2026, complaints engineer ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction ¿foreign matter (e.G.Hairs, insects) within primary pack (sterile products)¿ defect for the lot number 5c04810 and as result, no nonconformance / corrective and preventive actions (capa) (s) for this malfunction were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm) "sterile packaging inspection for nonconformities - visual attributes": frequency: every 30 minutes.Sample quantity: 1 market unit.Acceptance criteria: accept = 0| reject = 1.Defect rate analysis there has been 1 defective part confirmed to date from a lot size of (b)(4) products.This represents a defect rate of (b)(4), which was well within an appropriate acceptable quality level (aql) for this defect which should be (b)(4) based on our process instruction (pi).In addition, all of the in-process testing on this lot did not find a single defective unit, which confirms that the lot was unlikely to breach an acceptable quality level (aql) of (b)(4).To date, it was well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Personnel notification and training: as part of the investigation, the teams involved in the manufacturing of the affected product families were informed about the reported issue.The goal was to raise awareness and reinforce the importance of inspection protocols.Training sessions were carried out across all shifts, focusing on the potential failure mode, correct handling procedures, and the critical role of visual inspections.These sessions served as a reminder to remain vigilant and maintain high standards in daily operations.This effort helped ensure that everyone involved continues to follow established controls and remains attentive to any signs of deviation.Conclusion: no photographs for this complaint issue.Therefore, it was not possible to conduct an investigation for the reported issue.A review of batch records 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 discrepancies related to this issue were found within the documentation.Personnel involved in the manufacturing process were notified and retrained to reinforce awareness of the potential failure mode and the importance of inspection protocols, ensuring continued vigilance.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+
• 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 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 ; 3365424679
• MDR Report Key: 24016876
• Report Number: 9618003-2026-00029
• Device Sequence Number: 10555013
• Product Code: FRO
• UDI-Device Identifier: 00768455169559
• UDI-Public: 00768455169559
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 422606
• Device Lot Number: 5C04810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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