MAUDE Adverse Event Report: TOPS MEDICAL ARTICLES INDUSTRIES NANTONG INC DRIVE; PATIENT LIFT SLING

Model Number	13025
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Head Injury (1879)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a patient lift sling by an end user's husband, who stated that "the sling tore, and [his wife] fell to the ground and sustained a head injury." the end user did not seek any medical treatment.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: PATIENT LIFT SLING
• Manufacturer (Section D): TOPS MEDICAL ARTICLES INDUSTRIES NANTONG INC; south hezoucaojia town; qidong city, jiangsu 22621 5; CH 226215
• MDR Report Key: 16388793
• Report Number: 2438477-2023-00007
• Device Sequence Number: 5477774
• Product Code: FSA
• UDI-Device Identifier: 00822383103310
• UDI-Public: 00822383103310
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/15/2023
• Report Date (Section F): 02/15/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 13025
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2023
• Date Report to Manufacturer: 02/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 02/15/2023