MAUDE Adverse Event Report: Medline Industries, LP Medline; OCHSNER C SECTION SYS

Catalog Number	DYNJ81496B
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: OCHSNER C SECTION SYS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50255632
• Report Number: 1423395-2026-00517
• Device Sequence Number: 18673235
• Product Code: OHM
• UDI-Device Identifier: 10198459083402
• UDI-Public: 10198459083402
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: Health Professional
• Device Catalogue Number: DYNJ81496B
• Device Lot Number: 26EBJ430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female