MAUDE Adverse Event Report: HOLOGIC INCORPORATED PANTHER INSTRUMENT; IN-VITRO DIAGNOSTICS

Catalog Number	902615
Health Effect - Clinical Codes	Burn(s) (1757); Blurred Vision (2137)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) (customer) reported that one of their operators ((b)(6)) had splashed bleach into one of her eyes on.It happened when the operator was making bleach solution to clean panther work surface areas.The operator was not wearing any eye protective glasses or goggles.The operator washed her eye with water and then went to seek medical attention.The bleach had burned the outer layer of her affected eye and her vision has been blurry.The doctor has instructed the operator to wear goggles until the eye has healed and was given medical leave.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• MDR Report Key: 7067728
• Report Number: 2024800-2017-00027
• Device Sequence Number: 13678742
• Product Code: LSL
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2017

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: No Information
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/29/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other