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

Catalog Number	MDSMR116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the sling loop came unhooked from the lift, the patient fell, was hospitalized, and needed stitches.Additionally, it was reported while using a lift to lift another patient, the sling loop came unhooked from the lift, the patient fell, hit their head, and the patient died.
Additional Manufacturer Narrative
On 07/10/2024, it was reported that while using a lift to lift a patient, the sling loop came unhooked from the lift, the patient fell, was hospitalized, and needed stitches.No device malfunction was reported.An adverse event was filed under medwatch number 1417592-2024-00788 on 08/07/2024 to account for the lift involved in the reported incident.On 07/10/2024, it was reported that while using a lift to lift a patient, the sling loop came unhooked from the lift, the patient fell, hit their head, and the patient died.No device malfunction was reported.An adverse event was filed under medwatch number 1417592-2024-00790 was filed on 08/07/2024 to account for the lift involved in the reported incident.At the time the two (2) medwatches were filed, no product malfunctions were reported to have caused or contributed to the events.The reporting facility returned two slings, mdsmr115 and mdsmr116, to the manufacturer.The reporting facility was unable or unwilling to provide information on which sample was involved in either event and was unable or unwilling to confirm whether the samples were in use at the time of the event.Evaluation of the returned sling samples identified that there were no rips, cuts or tears visible on either of the slings and no device malfunction was reported.The incidents likely occurred due to customer misuse/mishandling however, a definitive root cause could not be confirmed.In an abundance of caution, a medwatch is being filed for each sling returned to the manufacturer.

• Brand Name: MEDLINE
• Common Device Name: SLING,MESH,FULL BODY,COMMODE,XL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23982043
• Report Number: 1417592-2026-00008
• Device Sequence Number: 13414052
• Product Code: FSA
• UDI-Device Identifier: 10884389128770
• UDI-Public: 10884389128770
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/06/2026

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
• Device Catalogue Number: MDSMR116
• Device Lot Number: 52522110001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: Unknown