MAUDE Adverse Event Report: Tops Medical Articles Industries Nantong Inc Drive Medical Sling 2/Cmde. Mesh, Lg 1/bx; LIFT, PATIENT, NON-AC-POWERED

Model Number	13221L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a sling by a letter from an attorney.According to the information received, the end user was in a patient lift when the lift strap broke, resulting in a fall.As a consequence of the fall, the end user reportedly sustained a fractured elbow, fractured hip, and fractured pelvis.Drive medical is currently investigating the incident, including attempting to inspect the device.An update will be filed if additional information becomes available.

• Brand Name: Drive Medical Sling 2/Cmde. Mesh, Lg 1/bx
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): Tops Medical Articles Industries Nantong Inc; south hezoucaojia town; qidong city, jiangsu 22621 5; CH 226215
• MDR Report Key: 50791934
• Report Number: 2438477-2026-00062
• Device Sequence Number: 9525351
• Product Code: FSA
• UDI-Device Identifier: 00822383103587
• UDI-Public: (01)00822383103587
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 13221L
• Device Catalogue Number: 13221L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• 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: 88 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/16/2026