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

Catalog Number	MDR107003ELO
Medical Device Problem Codes	Material Frayed (1262); Overheating of Device (1437); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pendant wiring is either damaged, fraying, or internal wires are exposed.Additionally, the customer contact reported that the pendant buttons do not work or are stuck, and the pendant becomes warm or hot to touch.The customer reported that they "received recall letter" and "there is a bolt on the foot part of the frame that is broken.".
Additional Manufacturer Narrative
It was reported that the pendant wiring is either damaged, fraying, or internal wires are exposed.Additionally, the customer contact reported that the pendant buttons do not work or are stuck, and the pendant becomes warm or hot to touch.The customer reported that they "received recall letter" and "there is a bolt on the foot part of the frame that is broken." no injuries were reported.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: BED, LOW FULL ELECTRIC, BASIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50213291
• Report Number: 1417592-2026-08530
• Device Sequence Number: 6122778
• 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: Health Professional
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026

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
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R25-242-X2
• Patient Sequence Number: 1
• Patient Sex: Unknown