MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED ONLY,4-MOTOR,HI/LOW,34.5W,LOCK

Catalog Number	FCE1385B
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "broken pendant.".
Additional Manufacturer Narrative
The customer reported that the pendant is cracked, and the images showed three buttons on the face of the pendant are pressed in and broken.A photo depicting the defect was provided and only a visual review of the defect could be conducted; after reviewing the photo, the pendant housing was found fractured around the hi-lo buttons, and the down button for the head section was completely broken, with missing pieces exposing the internal electronics.The investigation results were confirmed.Given the evidence provided in the photo, as well as the incident report, the root cause of this issue is unknown; no trends were identified for the specified material number and its corresponding defect type, and a replacement pendant was issued.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: BED ONLY,4-MOTOR,HI/LOW,34.5W,LOCK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: zelek alexander ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50775583
• Report Number: 1417592-2026-40864
• Device Sequence Number: 10561710
• Product Code: FNL
• UDI-Device Identifier: 10888277100022
• UDI-Public: 10888277100022
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/11/2026

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: FCE1385B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2025
• 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: 09/03/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown