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

THE CUSTOMER CALLED AND STATED THAT SHE HAS BEEN USING THE ALCOHOLIC WIPES THAT HAVE BEEN RECALLED AND SHE HAS BEEN IN THE HOSPITAL THE LAST FEW MONTHS FIVE TIMES FOR INFECTIONS. DURING A FOLLOW-UP CALL ON (B)(6) 2026, THE CUSTOMER REPORTED BEING IN AND OUT OF THE HOSPITAL FOR THE PAST FIVE WEEKS. THESE ISSUES BEGAN ON (B)(6) 2026, WITH SURGERY TO REMOVE A LIVER TUMOR AND THE INSERTION OF A BILIARY DRAIN TUBE WITH A BAG. TWO WEEKS LATER, A BLOCKAGE IN THE BAG RESULTED IN A SECOND SURGERY FOR REPLACEMENT. BY LATE ON (B)(6), SHE DEVELOPED A 103 DEGREE FEVER AND HER BLOOD PRESSURE DROPPED TO 50/60. THIS LED TO A THIRD SURGERY TO CHANGE THE BAG DUE TO AN INFECTION, WITH DOCTORS SUSPECTING SEPSIS. ALTHOUGH CULTURES AND BLOOD WORK WERE PERFORMED, SHE WAS UNSURE OF THE RESULTS AT THE TIME OF THE CALL BUT BELIEVED THEY WERE IN HER PORTAL, NOTING THAT THE HOSPITAL STRUGGLED TO IDENTIFY THE SOURCE OF HER RECURRING INFECTIONS. SHE HAS BEEN ON AMOXICILLIN FOR TWO MONTHS. SHE STATED THAT SHE IS A SEVEN-YEAR CANCER SURVIVOR AND IS NOW OFF CHEMOTHERAPY. SHE ALSO STATED THAT SHE STARTED USING THE ALCOHOL PREP PAD BOX SIX WEEKS AGO. SHE HAS BEEN INSERTING THE PADS INTO HER BILIARY TUBE BEFORE USING A SYRINGE TO CLEAR FLUID. ADDITIONALLY, SHE USES THE WIPES ON A THERMOMETER BEFORE PLACING IT IN HER MOUTH. THE NURSE HAS ALSO BEEN USING THESE WIPES WEEKLY TO CLEAN HER SKIN, WHICH HAS BECOME RAW AND RED. SHE MENTIONED BEING RUSHED FROM A MEDICAL URGENT CARE TO THE HOSPITAL AT ONE POINT DUE TO THESE INFECTIONS. SHE IS RECEIVING CARE AT (B)(6) HOSPITAL.

Additional Manufacturer Narrative

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