MAUDE Adverse Event Report: CONVATEC LTD L3W0600 - AQUACEL; NOT APPLICABLE

Model Number 420823

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, there was foreign matter (hair) in the dressing and the product was not used by the patient.Photographs depicting the issue were received from the complainant.

Manufacturer Narrative

Common device name : dressing,wound, hydrophilic.(b)(6).(b)(4).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

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

Manufacturer Narrative

This emdr is being submitted to correct manufacturing site.

Event Description

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

• Brand Name: L3W0600 - AQUACEL
• Type of Device: NOT APPLICABLE
• 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: 12873812
• MDR Text Key: 285944155
• Report Number: 1000317571-2021-00232
• 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: Other,Foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420823
• Device Lot Number: 1E01155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2021
• 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