MAUDE Adverse Event Report: Medline Industries, LP Medline; DBD-BED, LOW FULL ELECTRIC, BASIC

Catalog Number	MDR107003ELO
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿intermittently has to push some more than once and the pendant becomes warm or hot to touch¿.
Additional Manufacturer Narrative
It was reported that ¿intermittently has to push some more than once and the pendant becomes warm or hot to touch¿.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.

• Brand Name: Medline
• Common Device Name: DBD-BED, LOW FULL ELECTRIC, BASIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: melinda marquez ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50870323
• Report Number: 1417592-2026-49057
• Device Sequence Number: 10674570
• Product Code: LLI
• UDI-Device Identifier: 10080196546992
• UDI-Public: 10080196546992
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: MDR107003ELO
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-25-242-X4
• Patient Sequence Number: 1
• Patient Sex: Unknown