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 Code	Skin Tears (2516)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical drape stuck to patients skin when trying to remove it after case was finished, when removing skin drape it was "glued" to the patients skin and we had to exert force to get it off which resulted in patients skin being pulled off with the drape.
Additional Manufacturer Narrative
It was reported that "surgical drape stuck to patients skin when trying to remove it after case was finished, when removing skin drape it was "glued" to the patients skin and we had to exert force to get it off which resulted in patients skin being pulled off with the drape." this caused "breakdown and irritation in areas." there were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: OCHSNER C SECTION SYS
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50274852
• Report Number: 1423395-2026-00521
• Device Sequence Number: 10294124
• 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
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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
• Device Catalogue Number: DYNJ81496B
• Device Lot Number: 26EBJ430
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/17/2026
• 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: Unknown