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

Catalog Number	MDSCC10
Medical Device Problem Code	Insufficient Cooling (1130)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cryocube does not stay cool.
Additional Manufacturer Narrative
The customer states that she received the cryocube from the hospital and the cryocube does not stay cool; she is putting ice and water to the correct lines.Sample and/or photo provided? not available; pcn history reviewed? yes, and no product changes were identified that could have contributed to this product failure; quality control inspections records reviewed? yes, and inspection records could not be found.Investigation results: not confirmed, and no sample or photo of the defective product has been received therefore the issue cannot be confirmed at this time.Sample required to determine cause; a formal investigation will be conducted should the sample arrive, or if a detailed photo is provided, and the division will monitor through quarterly trending.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: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50889533
• Report Number: 1417592-2026-50529
• Device Sequence Number: 16118152
• Product Code: ILO
• UDI-Device Identifier: 10193489079425
• UDI-Public: 10193489079425
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/24/2026

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
• 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: 02/12/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown