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

Catalog Number	DYNJ69556B
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that prior to a cesarean section commencing in the obor, the radiopaque 18x18cm sponges were counted.They were separated and all tags pulled, with no concerns.Immediately prior to the procedure commencing, while moving sponges on the table, the scrub rn noticed that a tab was disconnected from the sponge.The sponge was removed from the field, and all tabs on remaining sponges were rechecked by pulling all tabs, with no further loose tabs identified.The customer contact was unable to provide further incident details.No medical intervention, serious injury, death, or follow-up care has been reported.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 scrub rn noticed that a tab was disconnected from the sponge.

• 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: 50087051
• Report Number: 1423395-2026-00452
• Device Sequence Number: 9804059
• Product Code: OHM
• UDI-Device Identifier: 10195327242510
• UDI-Public: 10195327242510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: DYNJ69556B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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