MAUDE Adverse Event Report: CONVATEC LTD KALTOSTAT - EXUDATE MANAGEMENT ALGINATE FORTEX DRESSING; DRESSING,WOUND,HYDROPHILIC

Model Number 168117

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

(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.(b)(4).

Event Description

It was reported ¿one piece of the product is not sealed properly.¿ the product was not used on or by a patient.Photographs depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

A batch record review indicates no discrepancies.Machine logs have been checked and no discrepancies were found.Preventive maintenance (pm) logs have been checked and all pm's were completed.Kaltostat cavity drs 2 grams was manufactured under lot number 7b02922.Lot number 7b02922 was sterilized and released on review of results.All the results were within specification and products were released in compliance with standard operating procedures.The production process, in process testing and packaging of products was run in accordance with process instructions for machine universal.A visual inspection in accordance with testing methods was completed at the beginning of the order and every hour following until the order was completed.No nonconformity was registered during the manufacturing process of lot 7b02922.There is another complaint for lot number 7b02922 for the same complaint issue.A photograph has been received and evaluated in accordance with work instructions.The photograph confirms the complaint issue and the expected product.Since manufacturing lot 7b02922 was manufactured the machine universal has moved buildings and has been completely revalidated in its new location.Operators have been made aware of this complaint issue.This complaint 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.

Event Description

To date no additional patient or event details has been received.

• Brand Name: KALTOSTAT - EXUDATE MANAGEMENT ALGINATE FORTEX DRESSING
• 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: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8780784
• MDR Text Key: 150711556
• Report Number: 1000317571-2019-00085
• Device Sequence Number: 1
• Product Code: NAC
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/01/2019
• Device Model Number: 168117
• Device Lot Number: 7B02922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1