MAUDE Adverse Event Report: HANDICARE HANDICARE; BLACK THREAD

Model Number	323117
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Caregiver stated that while transferring the patient from the bed to the wheelchair, the lift dropped while over the wheelchair.

• Brand Name: HANDICARE
• Common Device Name: BLACK THREAD
• Manufacturer (Section D): HANDICARE; 10888 metro ct.; maryland heights MO 63043
• Manufacturer (Section G): HANDICARE; 10888 metro ct.; maryland heights MO 63043
• Manufacturer Contact: lauren stover ; 10888 metro ct.; maryland heights, MO 63043
• MDR Report Key: 22820642
• Report Number: 3007802293-2025-00004
• Device Sequence Number: 15619808
• Product Code: FSA
• UDI-Device Identifier: 00810045510484
• UDI-Public: 00810045510484
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 323117
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown