MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER INSTRUMENT; HOLOGIC PANTHER, INSTRUMENT SYSTEM

Catalog Number	PRD-05490
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer initially contacted hologic to inquire about the contents of the panther bleach bottle, during which hologic learned of this event.Hologic informed customer that the panther bleach bottle contains a sodium hypochlorite (naocl) solution with concentration of 5%-8.25%.Customer additionally reported that this incident occurred while the operator was addressing an undeactivated waste message on the panther fusion plus instrument.Per customer lab procedure for undeactivated waste, operators add an equal volume of bleach to the liquid waste bottle before disposal.Hologic performed a risk assessment and noted no product impact.Hologic has not been informed of any adverse outcomes related to this issue.Other.
Event or Problem Description
On (b)(6) 2025, a customer reported that while changing the liquid waste on the panther fusion plus instrument (b)(6), an operator bumped the panther bleach bottle on a countertop and accidentally splashed bleach up into their eye.Operator was not wearing eye protection at the time and immediately flushed the eye with water.Customer reported there were no injuries and the affected operator had no subsequent issues with the impacted eye.Hologic has not learned of any further treatment or adverse outcomes related to this event.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: HOLOGIC PANTHER, INSTRUMENT SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 22947045
• Report Number: 2024800-2025-00060
• Device Sequence Number: 21084437
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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
• Device Catalogue Number: PRD-05490
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/02/2025
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown