MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Liko ComfortSling Plus, Mod 300; Lift, patient, non-ac-powered

Model Number	35300305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Hip Fracture (2349)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient fell during a transfer using a liko comfort sling plus sling.The patient was being transferred from a bed to a wheelchair over a distance of approximately three meters while suspended in the sling attached to a patient lift.During the transfer, the patient reportedly slipped through the sling and fell feet first to the floor, then rolled onto the right side and struck their head on the floor.As a result of the fall, the patient sustained bleeding wounds to the forehead and nose and complained of pain in the right knee.Subsequent medical evaluation confirmed a femoral neck fracture (hip fracture).It was indicated that the sling was being used in combination with a lift and sling bar manufactured by another company.The serial number on the sling was no longer visible due to frequent washing.No allegation of a device malfunction was reported.Baxter's investigation remains ongoing.No further information was available at the time of this report.
Additional Manufacturer Narrative
Initial reporter postal code: 02610.No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: Liko ComfortSling Plus, Mod 300
• Common Device Name: Lift, patient, non-ac-powered
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] NA 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50058386
• Report Number: 8030916-2026-00098
• Device Sequence Number: 13347900
• Product Code: FSA
• UDI-Device Identifier: 00887761983526
• UDI-Public: (01)00887761983526
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 35300305
• Device Catalogue Number: 35300305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown