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

Catalog Number	MDSMR115
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Vertebral Fracture (4520)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 while transferring a resident from the chair to bed, the "sling ripped", causing a "humeral neck fracture and rib fractures" from the fall.The customer reported after the incident occurred, they "called 911" and the resident is currently "hospitalized".The customer reported the sling was inspected prior to use and was in "good condition".No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, 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 customer, on (b)(6) 2025 while transferring a resident from the chair to bed, the "sling ripped", causing a "humeral neck fracture and rib fractures" from the fall.

• Common Device Name: SLING,MESH,FULL BODY,COMMODE,LARGE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21883766
• Report Number: 1417592-2025-00188
• Device Sequence Number: 8190095
• Product Code: FSA
• UDI-Device Identifier: 10884389128763
• UDI-Public: 10884389128763
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/22/2025

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: Health Professional
• Device Catalogue Number: MDSMR115
• Device Lot Number: 52524090001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 126 KG