MAUDE Adverse Event Report: HANGZHOU TIANCHEN SCALE EQUIPMENT CO., LTD DRIVE; SCALE, PATIENT

Model Number	FLSCALE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving a patient lift scale by the device provider who reported that the patient lift scale broke while in use and the end user fell resulting in multiple fractures.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: SCALE, PATIENT
• Manufacturer (Section D): HANGZHOU TIANCHEN SCALE EQUIPMENT CO., LTD; no.1 shunnan road; changle industrial zone; hangzhou city yuhang district, zhejiang 31112 1; CH 311121
• MDR Report Key: 50127279
• Report Number: 2438477-2026-00052
• Device Sequence Number: 10527651
• Product Code: FRW
• UDI-Device Identifier: 00822383002026
• UDI-Public: (01)00822383002026
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2026
• Report Date (Section F): 08/04/2026

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: FLSCALE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/10/2026
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2026
• 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: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/04/2026