MAUDE Adverse Event Report: HOLOGIC, INC LOCALIZER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	HB100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted at the time of this report a follow up mdr will include the dhr for the device.H6: health effect impact code: appropriate term/code not available: suggested code: additional tissue removed.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
Event or Problem Description
It was reported that on (b)(6) 2025, the device was reporting inconsistent readings.Due to the issue the physician removed additional tissue from the patient.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on february 7, 2025, the device was reporting inconsistent readings.Due to the issue the physician removed additional tissue from the patient.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted and there were no signs of physical damage.Functional testing was conducted; the device was tested, and the reader recognized the loop probe and surgical probe.The device performed the measurements as intended without interference or error.No issues were found during the test, and the device worked as intended.Therefore, the complaint cannot be confirmed.The complaint could not be confirmed, no errors or issues were found during the test, and the device worked as intended.The investigation included a comprehensive review of the certificate of compliance from the contract manufacturer, complaint data and risk assessment.Conclusion: the reported issue was not confirmed, no errors or issues were found during the testing, and the device worked as intended.Future events will be monitored and trended.Complaint confirmed: no device history record (dhr) review: the certificate of compliance of the contract manufacturer was reviewed for the corresponding lot number.Lot number: 50165974-1 manufacture date: 8/25/2021 expiration date: n/a basic unique device identifier: (b)(4).H6: health effect impact code: appropriate term/code not available: suggested code: additional tissue removed.

• Brand Name: LOCALIZER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21540488
• Report Number: 1222780-2025-00111
• Device Sequence Number: 17925621
• Product Code: NEU
• UDI-Device Identifier: 00855436007037
• UDI-Public: 00855436007037
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K163667
• 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): 02/26/2026

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: HB100
• Device Catalogue Number: HB100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown