D
Patient 1
(B)(6) CALLED MERZ NORTH AMERICA, INC TO REPORT THAT A PATIENT, FEMALE WAS INJECTED AT ANOTHER FACILITY WITH RADIESSE VOICE AND IS CURRENTLY IN THE ICU OF THIS HOSPITAL WITH AN AIRWAY OBSTRUCTION. HE STATED THAT THE ICU CALLED HIM 20 MINUTES AGO ASKING FOR INFORMATION ABOUT THE PRODUCT AND FOR A REVERSAL OF THE AIRWAY. HE STATED THAT HE HAD PRINTED THE RADIESSE VOICE INSTRUCTIONS FOR USE AND SENT IT TO THE ICU. (B)(6) AGREED TO A MEDICAL CONSULT (DISCUSSION OF THE CASE WITH A HEALTH CARE PROFESSIONAL). ON (B)(6) 2014 (B)(6) SPOKE WITH DR. (B)(6), A MERZ CONTRACTED PHYSICIAN. DR. (B)(6) STATED THAT (B)(6) HAD VERY VERY LITTLE CLINICAL INFORMATION ABOUT THE PATIENT AND THUS INFORMATION WAS VERY LIMITED AND ADVICE AND GUIDANCE WAS UNABLE TO BE PROVIDED. DR (B)(6) PROVIDED HIS CONTACT INFORMATION FOR HIM TO PROVIDE TO THE TREATING PHYSICIANS IN CASE HE/SHE WANTED TO CONTACT ME. DR (B)(6) HAVE NOT HEARD FROM ANYBODY ELSE ABOUT THIS INCIDENT. ON (B)(6) 2014 (B)(6), DIRECTOR OF ICU WAS CONTACTED. THE PATIENT, FEMALE HAD RESPIRATORY DISTRESS AND WAS INTUBATED. SHE IS CURRENTLY ON A VENTILATOR AND THERE ARE NO PLANS TO REMOVE THE VENTILATOR TODAY. SHE WAS NOT ABLE TO PROVIDE ANY INFORMATION REGARDING WHERE OR WHEN THE PATIENT WAS INJECTED. ON (B)(6) 2014 (B)(6), DIRECTOR OF ICU WAS CONTACTED. SHE WAS ASKED HOW THE PATIENT IS DOING. (B)(6) STATED THAT THE PATIENT IS DOING OK. SHE WAS THEN ASKED WHEN THE PATIENT CAME OFF THE VENTILATOR. (B)(6) SAID SHE THINKS IT WAS ON FRIDAY ((B)(6) 2014). SHE DOES NOT HAVE THE PATIENT'S CHART IN FRONT OF HER. SHE WAS ASKED IF THE PATIENT CAME INTO THE HOSPITAL UNCONSCIOUS. (B)(6) REPLIED THAT SHE DID NOT KNOW. FURTHER QUESTIONS WERE ASKED AND (B)(6) REPLIED THAT SHE DOES NOT KNOW AS SHE DOES NOT HAVE THE PATIENT'S CHART IN FRONT OF HER.