MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CRYOCUBE, UNIT, COLD THERAPY

Catalog Number	MDSCC10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they are concerned about moisture between the inner and outer shell and believes there may be a crack on inner shell causing leaking.".
Additional Manufacturer Narrative
The customer expressed concern about moisture between the inner and outer shell and suspected a possible crack in the inner shell causing leakage.Upon inspection, medline filled the unit with water and observed no leaks or visible cracks in the inner shell, and the pump was tested and is functioning properly.The complaint is not confirmed.No root cause was confirmed; the exact temperature of the water used by the customer is unknown, but it is possible that the introduction of ice water may have caused condensation between the inner and outer shell, and the division will continue to monitor this issue through trend analysis.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.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, UNIT, COLD THERAPY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50948898
• Report Number: 1417592-2026-54676
• Device Sequence Number: 10348774
• Product Code: ILO
• UDI-Device Identifier: 10193489079425
• UDI-Public: 10193489079425
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/29/2026

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: MDSCC10
• Device Lot Number: 07625030001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/18/2025
• 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: 07/15/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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