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
Initial reporter: complainant street address: (b)(6).Complainant city: (b)(6).Complainant state: (b)(6).Complainant postal code: (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 by the retailer that there was a foreign matter inside the individual packaging.The product was not used by the patient.The photographs depicting the issue were received from the complainant.
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 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 in-process stat sample quality checks were satisfactory.Kaltostat drs 7.5x12cm wt(1x10pk)sterint was manufactured under system application product (sap) code 1703039 and manufacturing lot number 2l00820 on 18 november 2022.Lot # 2l00820 was sterilized under reference id (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 2l00820.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue so was evaluated in accordance with work instructions (wi).The photos confirm the expected lot, product and complaint issue where a small, dark area on the dressing is shown in the images between the characters displaying the dressing size on the primary sachet.The sample was requested on 02nd june 2023, but it was not received by 27th july 2023.No physical sample has been received.The complaint does have a valid lot number; this complaint will be processed as a type 2 complaint with no physical sample.Should a sample be received for the complaint, the case will be re-opened and investigated under the type 2 evaluation criteria.Without the complaint sample, it was not possible to identify the foreign matter shown in the image, and therefore it was not possible to investigate the issue further.As such, no nonconformance (nc) or corrective and preventive actions (capa) record could be raised for this issue.A previous nonconformance (nc) has been raised in the past for contamination in the kaltostat product.While the foreign matter was different, it was still not possible to identify where the foreign matter entered the product.It is possible for foreign matter to enter the manufacturing process at rhymney and at deeside.The foreign matter is unlikely to be anything like excess silver as this product does not contain silver.As no complaint sample was received, it was not possible to identify the foreign matter or root cause.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.

• 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: 17207858
• Report Number: 1000317571-2023-00106
• Device Sequence Number: 6741768
• Product Code: NAC
• UDI-Device Identifier: 00768455122790
• UDI-Public: 00768455122790
• 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): 06/02/2023

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: 11/01/2025
• Device Model Number: 168212
• Device Lot Number: 2L00820
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2022
• 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