MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRIES NANTONG DRIVE DEVILBISS HEALTHCARE; LIFT, PATIENT, NON-AC-POWERED

Model Number	13223M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift sling by the end user's daughter who stated that the blue strap on the sling tore in half causing the end user to fall backwards.The end user broke their collarbone.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): TOPS MEDICAL ARTICLES INDUSTRIES NANTONG; south hezoucaojia town qidong; qidong city, jiangsu 22621 5; CH 226215
• MDR Report Key: 21379525
• Report Number: 2438477-2025-00012
• Device Sequence Number: 12877202
• Product Code: FSA
• UDI-Device Identifier: 00822383103679
• UDI-Public: (01)00822383103679(21)
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025
• Report Date (Section F): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13223M
• Device Catalogue Number: 13223M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/28/2025
• Event Location: Home
• Date Report to Manufacturer: 02/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Date Report Sent to FDA: 02/13/2025