MAUDE Adverse Event Report: Medline Industries, LP Medline; HHI C SECTION PACK-LF

Catalog Number	DYNJ82036A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the c-section drape allowed a significant amount of fluid to leak through it and onto the floor.No injuries to the patient occurred during the use of this drape.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the c-section drape allowed a significant amount of fluid to leak through it and onto the floor.

• Brand Name: Medline
• Common Device Name: HHI C SECTION PACK-LF
• Manufacturer (Section D): Medline Industries, LP; 1170 s northpoint boulevard; waukegan IL 60085 -675
• Manufacturer Contact: martin posada ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50766389
• Report Number: 1423395-2026-00666
• Device Sequence Number: 9460339
• Product Code: OHM
• UDI-Device Identifier: 10198459131134
• UDI-Public: 10198459131134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: DYNJ82036A
• Device Lot Number: 26DMF747
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown