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
Event or Problem Description
According to the facility contact, "surgical drape stuck to patient's skin when trying to remove it after case was finished" and "when removing skin drape, it was "glued" to the patient's skin and we had to exert force to get it off." per the customer contact, this "resulted in patient's skin being pulled off with the drape in some areas and a sticky residue left in other spots.".
Additional Manufacturer Narrative
According to the facility contact, "surgical drape stuck to patient's skin when trying to remove it after case was finished" and "when removing skin drape, it was "glued" to the patient's skin and we had to exert force to get it off." per the customer contact, this "resulted in patient's skin being pulled off with the drape in some areas and a sticky residue left in other spots." it was reported they were "unable to remove residue with soap, water, alcohol wipes" and "eventually tried convatec adhesive remover spray that we use for c-section bandage removal, and it helped to remove some of it." the customer stated, "however from rubbing patient's skin, she has breakdown and irritation in areas" as well as "a skin tear." per the customer contact, "this is the second patient in a week that this happened to." following the reported incident, it was reported that "they treated the skin tear", and the patient is "doing good." the customer contact noted no medical intervention or follow-up care was required.No additional details were provided regarding the customer reported incident.A sample is not available for evaluation.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 -275
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50252870
• Report Number: 1423395-2026-00515
• Device Sequence Number: 21374763
• 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 Age: 37 YR
• Patient Sex: Female
• Patient Race: White