WEBCOL

Additional Manufacturer Narrative

ADDED THE INITIAL REPORTER'S ADDRESS IN SECTION E1.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED VIA MEDWATCH THAT THE REPORTER STARTED TO DEVELOP A RASH AFTER PURCHASING AND USING THE ALCOHOL PREP PADS ON THEIR RIGHT HAND BUT THOUGHT IT WAS AN ALLERGIC REACTION TO SOMETHING. THE FIRST TIME SHE NOTICED THE RASH WAS WHEN SHE WENT OUT OF TOWN FOR (REDACTED BY FDA) IN 2025. SHE USED THEM TO SANITIZE HER PHONE, REMOTE CONTROLS OR ELECTRONIC DEVICES REGULARLY. THE RASH WAS AGGRAVATED BY MOST LIQUID HAND SOAPS AND WOULD TURN RED WITH A SCALY LOOK. AT TIMES IT WOULD APPEAR TO HEAL AND TURN THE SKIN ON TOP OF HER HAND DARK. MONTHS LATER SHE PURCHASED A SKIN CREAM FOR ECZEMA THAT WASN'T VERY EFFECTIVE AT ALL. WHILE ON VACATION WITH HER DAUGHTER TWO WEEKS BEFORE THE SAFETY RECALL WAS ANNOUNCED SHE NOTICED THAT HER HAND WAS ALSO DEVELOPING A RASH AND SHE HAD NOT USED THE ALCOHOL WIPES PRIOR TO THAT TIME. DURING THE VACATION IN (REDACTED BY FDA) 2026 SHE BEGAN TO SEE THE RASH ON HER LEFT HAND AS WELL AFTER USING IT ON A DAILY BASIS, AT LEAST TWICE A DAY. UPON THEIR RETURN FROM VACATION, SHE READ THE EMAIL FROM AMAZON WITH THE NOTICE FROM THE FDA. SHE IMMEDIATELY CONTACTED CARDINAL HEALTH TO REPORT THE ISSUE TO THEM AND AMAZON'S CUSTOMER SERVICE. SHE WAS TOLD BY AMAZON'S CUSTOMER SERVICE THAT A REPORT WAS BEING SENT OUT TO A SUPERVISOR BASED ON WHAT SHE TOLD THEM OVER THE PHONE AND THAT SHE WOULD BE CONTACTED. ALSO A REFUND WAS BEING ISSUED BY AMAZON FOR THE BOX OF ALCOHOL WIPES THAT SHE PURCHASED. AS OF TODAY SHE HAS NOT HEARD BACK FROM AMAZON BUT SHE MADE AN APPOINTMENT TO SEE A DERMATOLOGIST. SHE IS ALSO TAKING MEDICATION DUE TO A BREAST CANCER DIAGNOSIS IN (REDACTED BY FDA) 2022 SO SHE IS NOT SURE OF THE EXTENT OF HOW HER IMMUNE OR NERVOUS SYSTEM WAS COMPROMISED NEGATIVELY BY THE CONTAMINATED WIPES AS OF YET. SHE ALSO HAS EXTRA PACKETS FOR TESTING IF NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 27APR2026 STATED THAT THE PATIENT SAW A DERMATOLOGIST ON (B)(6) 2026 AND WAS GIVEN A PRESCRIPTION FOR MOMETASONE (ELECON) TO ASSIST WITH HEALING OF HER SKIN. THE DIAGNOSIS PROVIDED WAS FOR DERMATITIS AND SEBORRHEIC KERATOSIS. SHE HAS A FOLLOW UP WITH HER REGULAR DERMATOLOGIST IN JUNE. THE PATIENT STATED THAT TODAY THERE IS STILL RESIDUAL SCARRING PRESENT. THE LOT NUMBER IS NOT KNOWN.