MAUDE Adverse Event Report: HANDICARE USA, INC. HANDICARE; SLING, OVERHEAD SUSPENSION, WHEELCHAIR

Model Number	547810
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per staff, while transferring the patient from the bed that patient arrived in from outpatient setting to bariatric hospital bed using a hoyer that is approved for 1000lbs and a transfer sheet also approved for 1000lbs the transfer sheet ripped when lifting the patient over the bed.The patient was immediately lowered onto his outpatient bed and the manurer was aborted.The patient stated he was okay and not injured.The lift was about 4-5 inches above the bed when it ripped.

• Brand Name: HANDICARE
• Common Device Name: SLING, OVERHEAD SUSPENSION, WHEELCHAIR
• Manufacturer (Section D): HANDICARE USA, INC.; 10888 metro ct.; maryland heights MO 63043
• MDR Report Key: 24888243
• Report Number: 24888243
• Device Sequence Number: 9897324
• Product Code: INE
• UDI-Device Identifier: 00810045514659
• UDI-Public: (01)00810045514659
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/08/2026
• Report Date (Section F): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 547810
• Device Catalogue Number: 547810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/08/2026