MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; BAR,ASSIST,FLIP DOWN FOR FCE1232 BED

Catalog Number	FCE1232ABN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, a right lower leg "degloving injury" was sustained by a user of the device while transferring from a "wheelchair to bed." the user has been hospitalized in acute care for the "past two weeks" following surgery and wound vac placement.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, a right lower leg "degloving injury" was sustained by a user of the device while transferring from a "wheelchair to bed." the user has been hospitalized in acute care for the "past two weeks" following surgery and wound vac placement.
Additional Manufacturer Narrative
Update to h6: investigation findings (c).

• Common Device Name: BAR,ASSIST,FLIP DOWN FOR FCE1232 BED
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22921043
• Report Number: 1417592-2025-00428
• Device Sequence Number: 9144270
• Product Code: LWP
• UDI-Device Identifier: 40884389106427
• UDI-Public: 40884389106427
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 04/08/2026

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
• Device Catalogue Number: FCE1232ABN
• Device Lot Number: 54124090001
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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: 92 KG