VERAFORM ADAPTABLE TISSUE MARKER

Description of Event or Problem

A PRODUCT CALLED VERAFORM WAS IMPLANTED. THIS PRODUCT WAS PLACED IN THE BREAST WHICH REMAINS IN THE PATIENT FOR FUTURE IMAGING. THERE WAS SOME CONCERN REGARDING THE PRODUCT'S EXPIRATION DATE AFTER THE PRODUCT WAS USED. AFTER THE DATE WAS QUESTIONED, IT WAS BROUGHT TO MANAGEMENT'S ATTENTION. THE COMPANY WAS CONTACTED TO CLARIFY HOW THE EXPIRATION DATE SHOULD BE INTERPRETED, AND IT WAS DETERMINED AT THIS TIME THAT THE PRODUCT WAS EXPIRED. THE MANUFACTURER WAS CALLED TO CLARIFY THE EXPIRATION DATE, AS IT WAS A CONCERN HOW IT WAS WRITTEN. A REPRESENTATIVE OF THE VERAFORM COMPANY ALSO MISREAD AND SAID THE PRODUCT WAS NOT EXPIRED. THE CEO OF THE COMPANY SENT DATA SHOWING THE STABILITY OF THE PRODUCT WOULD NOT EXPIRE UNTIL JANUARY 9, 2025 FOR LOT 05-2108-001. SURGEON WAS MADE AWARE.