WEBCOL

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE SPECIFIC MANUFACTURING AND INSPECTION RECORDS WAS NOT POSSIBLE. HOWEVER, ALL PRODUCT LOTS ARE REQUIRED TO MEET ESTABLISHED ACCEPTANCE CRITERIA AND MUST SUCCESSFULLY PASS DEFINED VISUAL AND FUNCTIONAL INSPECTIONS PRIOR TO RELEASE. THERE WERE NO DEVICES OR PHOTOS RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THE REPORTED ISSUE. WE WILL CONTINUE TO MONITOR AND TAKE ADDITIONAL ACTIONS, AS APPLICABLE.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, HIS RHEUMATOID ARTHRITIS (RA) DOCTOR HAS BEEN TRYING TO FIGURE OUT WHAT¿S GOING ON. THE CUSTOMER HAD A MAJOR REACTION, BLOOD VASCULAR RASH FROM AN INFECTION, THE NIGHT AFTER TAKING HIS SHOT AND USING THE WIPE THAT WAS IN WITH ALONG WITH HIS SIMLANDI SHOT. THEN HE GOT A MESSAGE FROM HIS PHARMACY ABOUT THE WIPES. HE IS COVERED WITH A RASH THAT LOOKS LIKE LEUKOCYTOCLASTIC VASCULITIS. IT STARTED ON SAME LEG HE USED WIPE AND GAVE HIMSELF A SHOT. PER CUSTOMER, HE IS WAITING FOR ADDITIONAL TEST RESULTS.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.