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

Model Number	168210
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: complainant state: (b)(6) complainant country:(b)(6) name of affiliation: (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
It was reported that the product was sealed with the primary package which caused an open seal at the side of pack.The product was not used by the patient.The photographs depicting the issue were received from the complainant.
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 it was identified that pad miscuts had been seen during the batch production, for which a tech was required on line.All seal strength tests completed throughout the batch manufacture were satisfactory.Kaltostat drs 5x5cm wt (1x10pk) ster int was manufactured under sap code (b)(4) and manufacturing lot number 2c02168 on 23 mar 2022.Lot # 2c02168 was sterilized under run id 2173-27199a 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 2c02168.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 expected lot number, product and the complaint issue where a single dressing was found trapped in the seal.A corrective action / preventive actions (capa) was not raised for this complaint as a capa for a similar issue is currently open, for which this batch is within bounding.This product was manufactured on doyen 2, but has since been validated for production on doyen 3.It is therefore not possible to investigate this issue specifically as it is no longer produced on the doyen 2 line.As the other capa record was open for a dressing in seal issue for a batch produced on doyen 3, no further investigation is necessary for this issue as investigation and corrections will be found within tw 1688796 for the other batch.Previous to this recent capa, 3 other nonconformance's (ncs) have also covered open seal and dressing in seal issues.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: 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: 17388482
• Report Number: 1000317571-2023-00164
• Device Sequence Number: 5929401
• Product Code: NAC
• UDI-Device Identifier: 00768455122783
• UDI-Public: 00768455122783
• 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): 06/30/2023

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: 03/01/2025
• Device Model Number: 168210
• Device Lot Number: 2C02168
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2022
• 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