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

Catalog Number	MDSCC20
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water is not circulating to the pad.The unit would work intermittently, but sometimes the water would get hot, in the 90s f.
Additional Manufacturer Narrative
The customer stated that ¿water is not circulating to the pad, and the water gets hot,¿ and per troubleshooting, the unit would work intermittently, but sometimes the water would get hot, in the 90s f.Medline received one cryocube in used condition and tested it; the motor would barely work and was slow and weak sounding, and a test cryocube was used and the water did circulate through the customer¿s hose and pad.The customer complaint was confirmed, and the result of the pic testing was functional defect.The cause was documented as cannot determine cause w/received sample; the cryocube does not heat water, and the cooling is solely from ice cubes that need to be added by the end user just before using.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, COMBO, UNIT, UNIV PAD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50733289
• Report Number: 1417592-2026-36912
• Device Sequence Number: 16107070
• Product Code: ILO
• UDI-Device Identifier: 10193489079449
• UDI-Public: 10193489079449
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 07624050001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2024
• 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: 10/28/2024
• Initial Report FDA Received Date: 09/11/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown