MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE EXUFIBER; EXUDATE-ABSORBENT DRESSING

Model Number 709901

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/14/2024

Event Type  Injury  

Event Description

Pt (patient) had a surgical procedure on (b)(6) for pelvic exenteration.The pt was readmitted during on (b)(6) with a dehisced wound, 4cm x1cm and 10 cm deep.Exufiber was used on (b)(6) to remove slough from dehisced wound with good result.The exufiber snapped upon removal, on (b)(6) and a piece remained in the sacrum wound.The staff flushed the wound and used forceps to try and remove, but were unsuccessful.An additional surgery was required to remove the remaining piece of exufiber.

• Brand Name: EXUFIBER
• Type of Device: EXUDATE-ABSORBENT DRESSING
• 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: mary gill ; 5445 triangle parkway; suite 400; peachtree corners, GA 30092 ; 4706023891
• MDR Report Key: 18699301
• MDR Text Key: 335295266
• Report Number: 3004763499-2024-00003
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 8020673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

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: 709901
• Device Lot Number: 23048113
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2023
• 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
• Patient Age: 57 YR
• Patient Sex: Male