OPTIVIEW

Additional Manufacturer Narrative

A REPORT WAS MADE BY A SALE REPRESENTATIVE THAT THERE WAS AN INCIDENT WHERE A 12 YEAR-OLD PATIENT HAD A SEVERE ALLERGIC REACTION AND HAD TO BE TAKEN TO THE HOSPITAL DUE TO AN ANAPHYLACTIC SHOCK. TO THIS DATE, THE PATIENT IS STILL HOSPITALIZED. IT WAS STATED BY THE SALES REP THAT THEY SPOKE TO THE PRACTICE AND THE PRACTICE HAD RECEIVED THE OPTIVIEW FROM THE PREVIOUS OWNER WHEN THEY TOOK OVER THREE (3) YEARS AGO. THEY BELIEVE THAT THE OPTIVIEW WAS ORDERED AT LEAST FIVE (5) TO SEVEN (7) YEARS AGO. OPTIVIEW HAS A SHELF LIFE OF 1,800 DAYS (ABOUT FIVE (5) YEARS). AS THE PRODUCT WAS RETURNED TO THE FACILITY WITH NO LABELING OR ADDITIONAL INFORMATION CONFIRMING THE EXPIRY DATE. VISUALLY THE PRODUCT RECEIVED HAS NO MECHANICAL DEFECT, STANDARD COLOR AND SMOOTH SURFACE. SEVERAL ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION AND THE STATUS OF THE PATIENT, HOWEVER NO FURTHER INFORMATION WAS PROVIDED AND NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME.

Description of Event or Problem

A COMPLAINANT ALLEGED THAT A 12-YEAR-OLD PATIENT HAD A SEVERE ALLERGIC REACTION AFTER THE OPTIVIEW WAS PLACED AND HAD TO BE TAKEN TO THE HOSPITAL DUE TO AN ANAPHYLACTIC SHOCK. TO THIS THIS DATE THE PATIENT IS STILL IN THE HOSPITAL.