MAUDE Adverse Event Report: HOLOGIC, INC HORIZON; DENSITOMETER, BONE

Model Number	HORIZON-CI
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a horizon dxa scan of the hip and spine axial on (b)(6) 2025.The user site reports that on (b)(6) 2025, the patient contacted the user site to report that she was burned by the device.The user site reports that according to the patient, on (b)(6) 2025, the patient started to notice blistering on the front and back of the legs.The patient further reported to the user site that on the evening of (b)(6) 2025, the patient's legs "locked and went numb." it is reported that the patient did not seek medical attention and self-medicated by placing heating pads on the legs and taking norco and gabapentin, which the patient already had prescribed outside of this reported event.The user site reports that during the dxa scan on (b)(6) 2025, the technologist noticed multiple artifacts in the hip and spine images.The user site reports that the patient confirmed that they were "buckshot pellets." the user site reports that the patient has not contacted them again since the initial contact on (b)(6) 2025.Additionally, the user site reports that they have not observed any abnormalities with their horizon dxa device.A hologic field service engineer (fse) was dispatched to examine the device and found the device to be functioning in accordance with manufacturer specifications.The fse reports that the staff at the user site indicates that multiple patients have been scanned on the system since the reported incident without any further complaints.No further information is available.

• Brand Name: HORIZON
• Common Device Name: DENSITOMETER, BONE
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23357804
• Report Number: 3005496266-2025-00078
• Device Sequence Number: 15726247
• Product Code: KGI
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: HORIZON-CI
• Device Catalogue Number: HORIZON-CI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown