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

Model Number	13263E
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a sling used with a sit-to-stand lift by a provider, who stated that "the belt on sling doesn't stay tight and slides loose." the end user reportedly slipped out of the sling and sustained a head injury.The end user did not seek any medical treatment as a result of the incident.Multiple attempts to gather further information have been made, and to retrieve the product for evaluation, but drive has not received a response.Drive will continue to monitor complaints for any related trends.

• 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: 16787620
• Report Number: 2438477-2023-00035
• Device Sequence Number: 20267130
• Product Code: FSA
• UDI-Device Identifier: 00822383231723
• UDI-Public: 00822383231723
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023
• Report Date (Section F): 04/21/2023

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: Lay User/Patient
• Device Model Number: 13263E
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/31/2023
• Event Location: Home
• Date Report to Manufacturer: 04/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/21/2023