MAUDE Adverse Event Report: CONVATEC LTD L3W0250 - KALTOSTAT; DRESSING,WOUND,HYDROPHILIC

Model Number 168117

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2.Information was received from a doctor in (b)(6) and reported by a convatec employee.Contact office address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review indicates no discrepancies.Pm logs have been checked, and all pm's have been completed with no discrepancies.Affected amount: (b)(4).Kaltostat wnd pkg 2g was manufactured under sap code 1703037 and manufacturing lot number 0c02748.Lot # 0c02748 was sterilised under lot 2173-9650a and released on review of results of sterilisation provided by sterilisation company steris.All of the results were within specification and products were released.The production process, in process testing and packaging of products was run in accordance with (b)(4) for machine universal.Visual inspection in accordance with (b)(4) was completed at the beginning of the order and every hour following until the order was complete.No nonconformity was registered during the manufacturing process of lot 0c02748.This is the only complaint for the affected lot registered within the complaint system.A photograph had been received and evaluated.The photo confirmed the product and batch number expected.The photo did not confirm the complaint issue.The batch record had been reviewed and no discrepancies were found.All required in process testing was completed and all was found to be satisfactory.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.(b)(4).

Event Description

It was reported that the doctor found the fiber of kaltostat was difficult to remove from the surgery wound.The dressing fiber was not strong enough when removed from wound so it had some dressing residue in the wound.The product was used for less than 7 days.No harm was reported to the patient.A photograph was received from the complainant.

• Brand Name: L3W0250 - KALTOSTAT
• Type of Device: 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: 12479383
• MDR Text Key: 271946174
• Report Number: 1000317571-2021-00216
• Device Sequence Number: 1
• Product Code: NAC
• UDI-Device Identifier: 00768455122776
• UDI-Public: 00768455122776
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: 168117
• Device Lot Number: 0C02748
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1