MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SLING,MESH,FULL BODY,COMMODE,LARGE

Catalog Number	MDSMR115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Bone Fracture(s) (1870); Unspecified Tissue Injury (4559)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, a resident was being transferred using a sling with a full-body lift from a shower chair when the front and back right sides of the sling completely severed mid-transfer, causing the resident to fall to the floor.The patient was hospitalized for five days with a broken arm, wounds and bruises, and a fracture in her neck.Reported treatment included use of a right-arm immobilizer, cervical collar, and extensive wound care.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, on (b)(6) 2026, a resident was being transferred using a sling with a full-body lift from a shower chair when the front and back right sides of the sling completely severed mid-transfer, causing the resident to fall to the floor.The patient was hospitalized for five days with a broken arm, wounds and bruises, and a fracture in her neck.Reported treatment included use of a right-arm immobilizer, cervical collar, and extensive wound care.

• Brand Name: MEDLINE
• Common Device Name: SLING,MESH,FULL BODY,COMMODE,LARGE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24192540
• Report Number: 1417592-2026-00067
• Device Sequence Number: 8064723
• Product Code: FSA
• UDI-Device Identifier: 10884389128763
• UDI-Public: 10884389128763
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MDSMR115
• Device Lot Number: 52524080001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 99 KG