MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; C SECTION PACK

Catalog Number	DYNJT3687
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the drape has not stuck to the patient and has made a mess all over the doctors and floor.The drape does not stick to the patient and we would like a different pack that works the way it is supposed to work.The drapes are supposed to stick to the patient and it is not sticking to the patient.The drape does not stick on the patient and doesn't serve its purpose.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
The drape has not stuck to the patient and has made a mess all over the doctors and floor.The drape does not stick to the patient and we would like a different pack that works the way it is supposed to work.The drapes are supposed to stick to the patient and it is not sticking to the patient.The drape does not stick on the patient and doesn't serve its purpose.

• Brand Name: MEDLINE
• Common Device Name: C SECTION PACK
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25307168
• Report Number: 1423395-2026-00190
• Device Sequence Number: 15782765
• Product Code: OHM
• UDI-Device Identifier: 10198459345913
• UDI-Public: 10198459345913
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: DYNJT3687
• Device Lot Number: 25LBS211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/25/2025
• 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
• Patient Sex: Unknown