MAUDE Adverse Event Report: GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V. PRODIGY; DENSITOMETER, BONE

Model Number	F2
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ge healthcareâ's investigation is ongoing.A follow-up report will be submitted when the investigation has been completed.Legal manufacturer: hcs madison - 3030 ohmeda dr, usa madison, wi 53718.
Event or Problem Description
On (b)(6) 2025, (b)(6) reported an incident involving a prodigy densitometry system phantom.During handling, the phantom was accidentally dropped, striking the operatorâ's foot, causing a fracture in the right foot big toe.No device malfunction was reported; the event occurred during routine handling of the phantom.Although the injury occurred on (b)(6) 2025, the customer did not inform ge healthcare until 10-dec-2025.
Additional Manufacturer Narrative
Ge healthcare (gehc) completed an investigation into the reported event and determined the injury was associated with user handling of the encapsulated phantom.The user was transporting the phantom from a storage area to the system table using a carrying bag with handles.As the user approached the table, the handles were inadvertently released, resulting in the phantom dropping and impacting the users right toe.A gehc field engineer subsequently evaluated the phantom and confirmed that it remained within expected performance specifications; therefore, no replacement was required.Review of the event did not identify a need for user retraining, as the handling precautions are inherent to the activity and no device malfunction was observed.Based on the investigation, no additional corrective or preventive actions are indicated at this time.

• Brand Name: PRODIGY
• Common Device Name: DENSITOMETER, BONE
• Manufacturer (Section D): GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.; calle espana no. 300,; parque industrial huinala; apodaca C.P. 6664; MX C.P. 66645
• Manufacturer (Section G): GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.; calle espana no. 300,; parque industrial huinala; apodaca C.P. 6664; MX C.P. 66645
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI 53188
• MDR Report Key: 23868757
• Report Number: 9616047-2025-00002
• Device Sequence Number: 4605369
• Product Code: KGI
• UDI-Device Identifier: 00840682138345
• UDI-Public: (01)00840682138345(11)201221
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K982267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: F2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American