WEBCOL

Additional Manufacturer Narrative

A NON-CONFORMANCE RECORD REVIEW FOR THE REPORTED LOT NUMBER WAS CONDUCTED. ALL IN-PROCESS AND FINAL ACCEPTANCE INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THEY THINK THEY MAY HAVE AN INFECTION BECAUSE OF THE ALCOHOL PREP. ADDITIONAL INFORMATION RECEIVED STATED THE PATIENT WAS USING THE ALCOHOL PREPS TO CLEAN HIS LEG TO START A NEW SITE FOR A REMODULIN INJECTION SUB Q. THE PATIENT'S LEG BECAME PAINFUL MORE THAN NORMAL AND SWELLED UP 3 INCHES MORE THAN NORMAL. HIS LEG HAD A 102 TEMP ON IT UNTIL HE REMOVED THE SITE AND CLEANED IT VERY WELL. THE INJECTION POINT IS STILL VERY RED, AND THE PATIENT STILL HAS PAIN. THE REDNESS ON THE REST OF THE LEG HAS STARTED TO GO AWAY. THE PAIN IS TOLERABLE NOW WHICH IS DIFFERENT THAN ANY OTHER SITE REACTION THAT THE PATIENT HAS GOTTEN FROM THE MEDICINE. THE PATIENT DID NOT SEE A DOCTOR BUT DID SPEAK TO HIS PHARMACIST. NO MEDICATIONS WERE REQUIRED.