MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. Medline; Drape, surgical, exempt

Model Number	DYNJP3005
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was undergoing a cesarean section utilizing a medline surgical drape placed over the patients abdomen.When the drape was removed following the procedure, it left a hard, sticky residue on the patient skin.This required additional effort to remove from the patient in order to prevent skin breakdown.

• Brand Name: Medline
• Common Device Name: Drape, surgical, exempt
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 50897090
• Report Number: 50897090
• Device Sequence Number: 13452227
• Product Code: PUI
• UDI-Device Identifier: 10080196735679
• UDI-Public: (01)10080196735679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 06/29/2026
• Report Date (Section F): 06/29/2026

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: Other
• Device Model Number: DYNJP3005
• Device Catalogue Number: DYNJP3005
• Device Lot Number: 85823019173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 181 LB
• Date Report Sent to FDA: 06/29/2026