MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PACK,COLD,INSTANT,DLX SWTLSS,6.25"X9.5"

Catalog Number	MDS148000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: PACK,COLD,INSTANT,DLX SWTLSS,6.25"X9.5"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50673311
• Report Number: 1417592-2026-34035
• Device Sequence Number: 9228597
• Product Code: IMD
• UDI-Device Identifier: 00080196733371
• UDI-Public: 00080196733371
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/03/2026

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: MDS148000
• Device Lot Number: VN23217
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/05/2024
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male