MAUDE Adverse Event Report: CONVATEC LTD KALTOSTAT; DRESSING, WOUND, HYDROPHILIC

Model Number	168212
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
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: 1000317571.
Event or Problem Description
The distributor reported that, there was brown, dusty material on the dressing.The product was not used.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: medical device problem code: as per the information provided by complainant, for the issue brown, dusty material on the dressing, the imdrf med.Dev.Prob.Code d1501 (problems traced to the device, but the investigation could not identify the actual root cause (e.G.Design, manufacturing, component).) is not available for selection.H11: investigation summary.Complaint (b)(4) reported foreign matter on a single unit of kaltostat drs 7.5x12cm, system application product (sap) code 1703039, manufactured under lot 4k00455 on 12-oct-2024.A full batch record review was completed.All in-process and stat sample quality checks were satisfactory, and no discrepancies, deviations, or nonconformances were identified.The lot was sterilised under certification 2173-51155a on 21-oct-2025 and released by sterigenics following a review -results were within specification and products were released.Two photographs were provided and evaluated in accordance with work instruction (wi)-0359.The images confirmed the correct product and lot number.The observed material was assessed and identified as excess kaltostat fibre, not foreign matter.A full root cause investigation was not initiated.The issue was confirmed to be consistent with excess process-generated fibre ¿ an inherent material byproduct ¿ and not indicative of contamination.The batch met all release specifications, and no other complaints have been recorded for this lot in database.This is considered an isolated occurrence with no impact to product performance or patient safety.Additionally, the fibre¿s presence would have been difficult to detect by human inspection at validated line speeds.According to pd20-168 v2.0, the acceptable quality level (aql) for contamination allows up to 5 dressings in a batch of this size; 6 or more would warrant rejection.Based upon a sample of (b)(4) primary packs and batch size of (b)(4) primary sachets.As only one device was affected and no other complaints have been received, the issue remains within acceptable quality limits - no new corrective action / preventive actions (capa) is necessary at this time.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: 1000317571.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: KALTOSTAT
• Common Device Name: DRESSING, WOUND, HYDROPHILIC
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire, CH5 2 NU; UK CH5 2NU
• 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 ; 3365424679
• MDR Report Key: 22129422
• Report Number: 1000317571-2025-00044
• Device Sequence Number: 15296931
• Product Code: NAC
• UDI-Device Identifier: 00768455122790
• UDI-Public: 00768455122790
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: Other
• Device Model Number: 168212
• Device Lot Number: 4K00455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2024
• 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