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

Model Number	168117
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that one of the dressing was opened.The product was not used by patient.The photograph depicting the issue was also received from the complainant.
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.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary: a batch record review was completed and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Kaltostat wnd pkg 2g wt (1x5pk) ster int was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 3c04741 on (b)(6) 2023.This date is reflected as the start date for the batch within the batch record, but system application product (sap) identifies the batch was manufactured 21 march 2023.Lot # 3c04741 was sterilized under (b)(4) and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3c04741.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the product, lot and expected complaint issue where an open seal can be seen in a primary sachet.The complaint sample was requested on(b)(6) 2024, but was not received within 30 days or before the complaint needed to be closed.An non-conformance (nc) record was opened and escalated to a corrective action / preventive actions (capa) in relation to kaltostat out of specification rope product causing open seals or incomplete seals in the primary pack as the kaltostat rope was too thick.From the non-conformance (nc) investigation, the assignable root cause was that the autoleveller used to control weights for the machine that manufactures the raw rope product at rhymney is at the end of its life due to machine parts being obsolete.Investigation continues to identify how this can be addressed to prevent recurrence.A planned deviation is in place for running the machine until improvement actions can be implemented.This issue will be monitored through the post market product monitoring review process.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 LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18541776
• Report Number: 1000317571-2024-00005
• Device Sequence Number: 20778429
• Product Code: NAC
• UDI-Device Identifier: 00768455122776
• UDI-Public: 00768455122776
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 12/27/2023

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 Expiration Date: 03/01/2026
• Device Model Number: 168117
• Device Lot Number: 3C04741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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