MAUDE Adverse Event Report: Productos Medline S.A. de C.V. Medline; C-SECTION PACK

Catalog Number	DYNJ30064R
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The plastic is separating from the blue paper/fabric (and there is a sticky residue left on our patients when the plastic covers the areas that have been cleaned with chloraprep).
Additional Manufacturer Narrative
It was reported that the plastic is separating from the blue paper/fabric (and there is a sticky residue left on our patients when the plastic covers the areas that have been cleaned with chloraprep).It is unknown how the patient is doing and if any injury occurred as a result.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.

• 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--275
• MDR Report Key: 50201460
• Report Number: 1423395-2026-00484
• Device Sequence Number: 5482368
• Product Code: LRO
• UDI-Device Identifier: 10198459241208
• UDI-Public: 10198459241208
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: DYNJ30064R
• Device Lot Number: 26EBM199
• 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: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• 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
• Patient Sex: Unknown