MAUDE Adverse Event Report: WELCH ALLYN, INC. 5002-KX-B; SCALE, STAND-ON, PATIENT

Model Number	901109
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported power supply had exposed wiring.There was no adverse event reported.
Additional Manufacturer Narrative
The welch allyn masted scales are intended to be used by clinicians for weighing patients up to 660 pounds (300 kg) for model 5122, up to 880 pounds (400 kg) for models 5002 and 6002.Masted scales can make contact with a patient¿s hands and feet.Contact duration is intended to be limited to less than 30 seconds.The customer refused to return the device and was provided with the replacement part #s to resolve the malfunction.Contact with exposed electrical wire can result in electrical injury.

• Brand Name: 5002-KX-B
• Common Device Name: SCALE, STAND-ON, PATIENT
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street; skaneateless falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 23696721
• Report Number: 1316463-2025-00093
• Device Sequence Number: 10375880
• Product Code: FRI
• UDI-Device Identifier: 00732094227314
• UDI-Public: 732094227314
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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
• Device Model Number: 901109
• Device Catalogue Number: 5002-KX-B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown