MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE MESALT; DRESSING, WOUND HYDROPHILLIC

Model Number 286080

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Bacterial Infection (1735); Foreign Body In Patient (2687)

Event Date 04/14/2022

Event Type  Injury  

Event Description

A report was received that stated the dressing was coming apart on removal.On (b)(6) 2022, additional information was received which stated pieces of the dressing were found in the wound approximately 6 weeks after starting use as daily packing for a deep wound on bottom of the foot.It is not known how long the pieces were left in the wound, but is estimated as 4-5 weeks due to delayed wound healing and infection.The patient required longer term antibiotics via picc and deep wound debridement.The patient was recovering at the time of this report.No additional information has been made available.

• Brand Name: MESALT
• Type of Device: DRESSING, WOUND HYDROPHILLIC
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer (Section G): MOLNLYCKE HEALTH CARE; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• Manufacturer Contact: pat strahl ; 5445 triangle parkway; suite 400; peachtree corners, GA 30092 ; 4042700985
• MDR Report Key: 15280346
• MDR Text Key: 298455621
• Report Number: 3004763499-2022-00007
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 286080
• Device Lot Number: 19271787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention