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

Model Number	13223M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	08/27/2025
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 provider who stated that the strap snapped, and the end user fell, reopening a wound on their leg.The right above the knee amputation site, that was reopened, had antibiotics applied to the site with bandages.Product labeling states, "inspect patient slings for wear prior to each use.If signs of tearing, fraying or wear are found discard the sling immediately; worn out slings are not safe for use and may result in injury or death." as part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare received the serial number of the device.The serial number of the device is (b)(6).Section d4 was updated with the serial number (b)(6).Section d9 was updated with the date returned to manufacturer of 10/08/2025.

• Brand Name: DRIVE DEVILBISS HEALTHCARE SLING FULL BODY MESH
• 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: 23084764
• Report Number: 2438477-2025-00045
• Device Sequence Number: 18770955
• Product Code: FSA
• UDI-Device Identifier: 00822383103679
• UDI-Public: (01)00822383103679
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/03/2025
• Report Date (Section F): 12/03/2025

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/03/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/03/2025