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

Model Number	168214
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor complained to the distributor that he was using company¿s known dressing for at least eight years.He mentioned that in the last three months of treating a patient at known hospital, he and his colleagues had found that company¿s known dressing, no longer had the hemostatic quality which it earlier had.Their patient had bad soakage of their dressings overnight in spite of heavy padding dressing over the company¿s known dressing.The duration of use was average of 12 hours, less than 24 hours.The wound was donor area, and the patient was not on anticoagulants.No photo is available at this time.
Additional Manufacturer Narrative
E1: complainant city: (b)(6).Complainant country: united arab emirates.Hospital name: (b)(6).Name of affiliation: (b)(6).It was also reported that there were twelve patients involved.Hence, separate reports are being submitted for the other patients involved.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
A batch record review was completed and no discrepancies were found.Kaltostat drs wt 10x20cm 1x10pk ster eur was manufactured under system application product (sap) code 1226579 and manufacturing lot number 2m00714 on 10 december 2022.Lot # 2m00714 was sterilized under reference (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 2m00714.This is the only complaint for this affected lot number in database.This complaint is related to 11 other complaints, as noted above, received from the same complainant.This complaint is for an absorption issue with a single patient.Parent case is for absorption issue with kaltostat (patient 1).Sister cases are absorption issue with kaltostat (patient 2), absorption issue with kaltostat (patient 3), absorption issue with kaltostat (patient 4), absorption issue with kaltostat (patient 5), absorption issue with kaltostat (patient 6), absorption issue with kaltostat (patient 7), absorption issue with kaltostat (patient 8), absorption issue with kaltostat (patient 9), absorption issue with kaltostat (patient 10), absorption issue with kaltostat (patient 11) and absorption issue with kaltostat (patient 12).No photographs were received for this issue, so could not be evaluated in accordance with work instructions (wi).Samples were requested from the known batch, which were initially available, but were not received at the same times as the related samples from lot 3d01546 and lot 2f02855.As the samples were not received, it was not possible to confirm the complaint or identify if the complaint is justified.As no images were received and no samples were received for this known batch, it was not possible to fully investigate the absorbency issue associated with this batch.Unused samples from the related known batches (3d01546 and 2f02855) were received, and following laboratory testing against the product specifications for absorbency, the dressings were confirmed to be within specification.As it was not possible to substantiate the complaint or complete testing for this known batch, there was no evidence of nonconformance against the specification.No corrective action / preventive actions (capa) or non-conformance (nc) was raised for the issue.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: 18094116
• Report Number: 1000317571-2023-00305
• Device Sequence Number: 5945707
• Product Code: NAC
• UDI-Device Identifier: 00768455122813
• UDI-Public: 00768455122813
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: Health Professional
• Device Expiration Date: 08/01/2025
• Device Model Number: 168214
• Device Lot Number: 2M00714
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2022
• 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