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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LO FULL ELC BED, 450 LB

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Medline Industries, LP MEDLINE; LO FULL ELC BED, 450 LB Back to Search Results
Catalog Number MDR107003LO
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/10/2023
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that "they are having issues with the bed not going down properly and stopping halfway down.".
 
Additional Manufacturer Narrative
The customer advised they are having issues with the bed not going down properly and stopping halfway down.The complaint could not be confirmed as there were no lot/serial numbers, samples, pictures or videos received.Without a sample received, it is difficult to determine a true root cause for the reported issue.Should the sample/detailed picture become available, the complaint will be reopened and investigated accordingly.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.
 
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Brand Name
MEDLINE
Common Device Name
LO FULL ELC BED, 450 LB
Manufacturer (Section D)
Medline Industries, LP
three lakes drive
northfield IL 60093 -275
Manufacturer Contact
sullivan bluhm
three lakes drive
northfield, IL 60093--275
MDR Report Key50931533
Report Number1417592-2026-52909
Device Sequence Number13451776
Product Code LLI
UDI-Device Identifier40080196325901
UDI-Public40080196325901
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Type of Report Initial
Report Date (Section B) 09/24/2026
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 NumberMDR107003LO
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 07/10/2023
Initial Report FDA Received Date09/29/2026
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 Number1
Patient SexUnknown
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