MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; DBD-LOWER EXTREMITY PACK

Catalog Number	DYNJT3367
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there was visible fluid (combination of blood from the patient and from the irrigation fluid used during the procedure) seepage through the gown while dr.(b)(6) was gowned and actively working in the surgical field.The leak was identified after the procedure when the surgeon took off his gown.There were no visible cuts or any signs of degradation identified during the donning of the gown.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Seepage through the gown while doctor was gowned and actively working in the surgical field.

• Brand Name: MEDLINE
• Common Device Name: DBD-LOWER EXTREMITY 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: 25174940
• Report Number: 1423395-2026-00154
• Device Sequence Number: 21380036
• Product Code: LRO
• UDI-Device Identifier: 10198459324277
• UDI-Public: 10198459324277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: DYNJT3367
• Device Lot Number: 26ABJ354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2026
• 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