Description of Event or Problem · 1
AS PER COMPLAINT RECEIVED FROM (B) (6), AT APPROXIMATELY 13:00 PM, DR. (B) (6) INFORMED MR (B) (4), SALES REPRESENTATIVE OF (B) (4), ABOUT THE FOLLOWING INCIDENT AT (B) (6) HOSPITAL: A FEMALE PATIENT VISITED THE HOSPITAL, IN ORDER TO HAVE A URINE CYTOLOGY TEST. IN ORDER TO PROCEED WITH THE TEST, THE RESPONSIBLE NURSE PROVIDED THE PATIENT WITH THE CYTOLYT SOLUTION. INSTEAD OF URINATING IN THE CONTAINER, HOWEVER, THE PATIENT INGESTED APPROXIMATELY 2/3 OF THE CYTOLYT SOLUTION. FOLLOWING COMMUNICATION WITH MRS. (B) (6), MR. (B) (4) CONTACTED (B) (4) AND PASSED ON THIS INFORMATION TO MRS. (B) (4), BUSINESS UNIT MANAGER OF CYTYC IN (B) (4) AND TO MRS. (B) (4), PHARMACO/MD VIGILANCE, RESPONSIBLE PERSON AT (B) (4). PATIENT WAS HOSPITALIZED AND A TREATMENT WAS REQUIRED. GASTRIC LAVAGES WERE PERFORMED AT (B) (6) HOSPITAL, AS WELL AS (B) (6) HOSPITAL, WHERE THE PATIENT WAS TRANSFERRED LATER THAT DAY FOR MEDICAL AID. PER LATEST INFORMATION RECEIVED FROM (B) (4) TODAY, PATIENT IS RECOVERED AND SHE WILL BE KEPT UNDER OBSERVATION IN THE HOSPITAL FOR SAFETY REASONS UNTIL TOMORROW.