WEBCOL

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT HER HUSBAND WAS DIAGNOSED WITH STAGE 4 BILE DUCT CANCER. IN THE FALL OF LAST YEAR HE STARTED HAVING REALLY SERIOUS INFECTIONS THAT BROUGHT HIM REPEATEDLY TO (B)(6) IN (B)(6). THE MOST SERIOUS WAS SEPSIS AND THEY THOUGHT THEY LOST HIM ON THAT VISIT. THEY FOUND OUT ABOUT THE RECALL OF THE ALCOHOL WIPES AND WAS ASTOUNDED. AT ONE POINT SHE WAS GIVING HIM ANTIBIOTICS THROUGH HIS PICC LINE 5X A DAY PLUS HIS TPN. FAITHFULLY SHE WOULD USE OUR WIPES. WHEN THEY STOPPED USING THE WIPES, THE INFECTIONS ALSO STOPPED. THE CUSTOMER STATED THAT THEIR TIME WITH HER HUSBAND IS SO PRECIOUS. HE HAD BEEN ABLE TO WORK REMOTELY UNTIL THE CONSTANT HOSPITALIZATIONS MADE IT IMPOSSIBLE! SHE WAS UNABLE TO WORK, HIS TWIN SISTER AS WELL AND HER DAUGHTER HAS HAD TO PUT HER LIFE ON HOLD REPEATEDLY TO WATCH THEIR HOUSEHOLD WHILE THEY WERE HOSPITALIZED. WHAT WAS TAKEN FROM THEM CANNOT BE MEASURED. SHE STATED THAT OUR COMPANY SHOULD BE ASHAMED FOR THE MAIN AUDIENCE BEING AFFECTED BY THIS BEING THOSE WITH COMPROMISED IMMUNE SYSTEMS. THERE WAS PAPERWORK SENT WITH THEIR SUPPLIES BUT IRONICALLY THEY WERE AT AN EMERGENCY TRIP TO THE HOSPITAL AND MISSED IT. AND HOW DID IT TAKE SO LONG WHEN THE INITIAL DISTRIBUTION WAS IN SEPTEMBER AND THEY ONLY JUST FOUND OUT ABOUT IT. THIS SHOULD HAVE BEEN BROUGHT TO THEIR ATTENTION IN A MAJOR WAY. THIS HAS PUT THEM THROUGH HELL. ADDITIONAL INFORMATION RECEIVED ON 23APR2026 STATED THAT THEIR HOSPITALS STAYS AT (B)(6) IN (B)(6) WERE: (B)(6) 2025-(B)(6) 2025, (B)(6) 2025-(B)(6) 2025, (B)(6) 2025- (B)(6) 2026, (B)(6) 2026, (B)(6) 2026-(B)(6) 2026, (B)(6) 2026-(B)(6) 2026, (B)(6) 2026- (B)(6) 2026 STARTED OFF IN ICU. THERE WERE SURROUNDING DAYS AT THEIR LOCAL HOSPITAL IN (B)(6) BEFORE THEY WERE ABLE TO GET A BED AT (B)(6) IN (B)(6). ADDITIONALLY, THE CUSTOMER STATED THAT PRIOR TO (B)(6) 2025, THE PATIENT HAD BEEN FEELING GOOD AND HIS CANCER HAD NOT PROGRESSED. ONE OF THE LOT NUMBERS IS 25K004262. SHE STATED THAT THERE IS ONE OTHER LOT NUMBER THAT SHE HAS TO TRACK DOWN FROM THE PATIENT. THEY DO HAVE THE REMAINDER OF THE BOXES. THEY STOPPED USING THE WIPES WHEN THEIR DAUGHTER TOLD THEM ABOUT THE RECALL THAT SHE HAD HEARD ABOUT ON TIKTOK AND THEN RESEARCHED FURTHER. THE PATIENT HAS NOT HAD ANOTHER INFECTION SINCE THEY STOPPED USING THE WIPES.

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. INSPECTION RESULTS WERE WITHIN ACCEPTABLE LIMITS, AND NO MANUFACTURING OR INSPECTION ANOMALIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. SAMPLES WERE PROVIDED FOR EVALUATION, BUT THE REPORTED ISSUE COULD NOT BE OBSERVED AT THIS TIME. 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.