BIONIX ACCU-TATT

Description of Event or Problem

THE PATIENT REPORTS A MALFUNCTION INVOLVING THE ACCU-TATT DEVICE BY BIONIX DURING RADIATION THERAPY ON (B)(6) 2024. THE DEVICE, WHICH UTILIZES PREFILLED SYRINGES FOR SKIN MARKING, ALLEGEDLY DISPENSED AN EXCESSIVE AMOUNT OF INK. AS A RESULT, PERMANENT INK LEAKED BOTH EXTERNALLY ON THE PATIENT¿S SKIN AND INTERNALLY, CREATING A PERMANENT MARK APPROXIMATELY 2 ½ INCHES IN SIZE ON THE TORSO ADJACENT TO THE LEFT BREAST. FOLLOWING THE INCIDENT, THE HOSPITAL CONDUCTED AN INVESTIGATION BUT COULD NOT CONCLUSIVELY DETERMINE WHETHER THE MALFUNCTION WAS DUE TO THE DEVICE ITSELF OR IMPROPER ADMINISTRATION DURING THE PROCEDURE. DESPITE THE UNCERTAINTY, THE HOSPITAL ACCEPTED PARTIAL RESPONSIBILITY AND SETTLED THE MATTER WITH THE PATIENT. SUBSEQUENTLY, THE HOSPITAL DISCONTINUED THE USE OF THE ACCU-TATT DEVICE. THE PATIENT CONTACTED BIONIX TO REPORT THE INCIDENT. HOWEVER, THE COMPANY DECLINED TO ACCEPT ANY RESPONSIBILITY, ASSERTING THAT THE ISSUE WAS SOLELY ATTRIBUTABLE TO THE HOSPITAL¿S ADMINISTRATION OF THE DEVICE. THE PATIENT FEARS THE POTENTIAL FOR THE INK TO SPREAD FURTHER WITHIN HER BODY, RAISING CONCERNS ABOUT LONG TERM HEALTH IMPLICATIONS. SURGERY WASN¿T OPTION AS THE PERMANENT MARK WAS TO BIG TO MAKE AN INCISION.