MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LIFT,PAT,HYDRAULIC,6 POINT CRD,NO SLING

Catalog Number	MDS88200HL
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "hoyer lift broke" and "the piece that connects handle broke , cannot use to lift".
Additional Manufacturer Narrative
The customer reported the hoyer lift broke and "the piece that connects handle broke , cannot use to lift"; the complaint states the issue did not occur during use and no injury occurred.The investigation documented that sample and/or photo provided was not available, medline quality had yet to receive the requested information from the customer despite follow up, finished good/component trending was performed with no trends identified, and quality control inspection records were reviewed.Investigation results were not confirmed.Root cause was not determined; the cause was "sample required to determine cause," 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,PAT,HYDRAULIC,6 POINT CRD,NO SLING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50778627
• Report Number: 1417592-2026-41380
• Device Sequence Number: 9825857
• Product Code: FSA
• UDI-Device Identifier: 40884389144825
• UDI-Public: 40884389144825
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/14/2026

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: MDS88200HL
• Device Lot Number: 03522050001
• Was Device Available for Evaluation?: No
• 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: 11/05/2025
• 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