MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PATIENT,STAND ASSIST,ELECTRC,40

Catalog Number	MDS400SAB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the wheel has literally split in half and broke apart.".
Additional Manufacturer Narrative
It was reported that customer stated that the wheel is fractured in half; the customer later stated, "the piece is not what came with the lift, that looked more like a key ring, and those have broken," and stated there have been no resident injuries or falls.Based on the photo evidence provided by the customer, the product appears to be in used condition due to the wear on the caster; visual review found the plastic of one locking caster has fractured and appears to be splitting in half off of the caster, and additional photos showed the customer has replaced the circular rings attached to the hooks on the 4-point boom with rectangular shaped rings.The investigation results were confirmed.The root cause of this issue with the caster is unknown, and the ring issue would be an issue of customer use/misuse; no trends were identified, no product changes were identified that could have contributed to the alleged product failure, and the division will monitor complaints through quarterly trending.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: LIFT,PATIENT,STAND ASSIST,ELECTRC,40
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915991
• Report Number: 1417592-2026-52074
• Device Sequence Number: 17478942
• Product Code: FSA
• UDI-Device Identifier: 10193489019254
• UDI-Public: 10193489019254
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/25/2026

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: MDS400SAB
• Device Lot Number: 68722042597
• 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: 09/23/2025
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown