MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; WOUND DRESSING KIT

Model Number	DYNDL1225
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Defective laceration tray- forceps had punctured through plastic packaging; forceps were missing rubber closure device.Forcep tip appears damaged.Two separate trays had forceps with damaged tips.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: WOUND DRESSING KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 22352623
• Report Number: 22352623
• Device Sequence Number: 8081579
• Product Code: MCY
• UDI-Device Identifier: 10193489365108
• UDI-Public: (01)10193489365108
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025
• Report Date (Section F): 06/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNDL1225
• Device Catalogue Number: DYNDL1225
• Device Lot Number: 25CBU391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/23/2025