MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CRYOCUBE, COMBO, UNIT, UNIV PAD

Catalog Number	MDSCC20
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this item is leaking at the seals.".
Additional Manufacturer Narrative
The customer stated that the unit is leaking at a seal, and the images showed the connection between the pad hose and the main hose of the unit is dripping/leaking.A photo depicting the defect was provided and only a visual review of the defect could be conducted; a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed; after reviewing the photo, the connecting tubing between the pad hose and the main hose of the unit appeared to be slightly dripping/leaking water onto the paper towel below.Given the evidence provided in the photo, as well as the incident report, the root cause of this issue is unknown, and the division will monitor through trending.There were no reports of death, serious injury, medical intervention, or follow up care.This is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: CRYOCUBE, COMBO, UNIT, UNIV PAD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884653
• Report Number: 1417592-2026-50053
• Device Sequence Number: 18830093
• Product Code: ILO
• UDI-Device Identifier: 10193489079449
• UDI-Public: 10193489079449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 09/23/2026

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: MDSCC20
• Device Lot Number: 07624020005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown