MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ALARM,TAMP-RESISTANT,LED/DUAL PAD,EA

Catalog Number	MDT8520TL
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: ALARM,TAMP-RESISTANT,LED/DUAL PAD,EA
• 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: 50938720
• Report Number: 1417592-2026-53913
• Device Sequence Number: 21266006
• Product Code: KMI
• UDI-Device Identifier: 10193489020113
• UDI-Public: 10193489020113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 17
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: MDT8520TL
• 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: 03/19/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown