WEBCOL

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 USED THESE PREP PADS FOR TWO SPECIFIC MEDICAL AND HYGIENE PURPOSES: SANITIZING SKIN SITES FOR REGULAR TESTOSTERONE INJECTIONS AND SANITIZING HER ELECTRIC RAZOR BEFORE FACIAL GROOMING. THE ADVERSE EVENTS BEGAN AS LOCALIZED ABSCESSES AT THE INJECTION SITES AND ON HER FACE IN THE AREAS WHERE THE SANITIZED RAZOR WAS USED. DESPITE STOPPING USE OF THE PADS, THE CONDITION HAS PROGRESSED AND SPREAD SYSTEMICALLY. CURRENT CLINICAL SYMPTOMS: TISSUE NECROSIS: THE REPORTER STATED SHE HAS ACTIVE, PROGRESSIVE NECROSIS ON THEIR FACE, SPECIFICALLY ON HER LIP, CHEEK, AND NEAR HER EAR. SHE STATED SHE HAS EXPERIENCED SPONTANEOUS TISSUE LOSS, INCLUDING A PORTION OF HER EYEBROW FALLING OFF. SYSTEMIC VASCULAR ISSUES: SHE HAS PERSISTENT "LACY BRUISING" (LIVEDO RETICULARIS) ON HER CALVES THAT HAS REMAINED FOR WEEKS. SEVERE EDEMA: HER LEGS ARE SIGNIFICANTLY SWOLLEN, TIGHT, AND HOT TO THE TOUCH. THE PRESSURE AND SWELLING ARE SO SEVERE THAT SHE IS UNABLE TO SLEEP IN A HORIZONTAL POSITION AND MUST REMAIN UPRIGHT. ABSCESSES: THE INITIAL ABSCESSES HAVE BEEN "PROBLEM CHILDREN," RECURRING AND SPREADING TO OTHER AREAS OF THE BODY. CONCLUSION: THE TIMING AND LOCATION OF THE INITIAL INFECTIONS DIRECTLY CORRELATE WITH THE USE OF THE RECALLED WEBCOL WIPES. THE CONDITION HAS TRANSITIONED FROM LOCALIZED INFECTION TO SYSTEMIC TISSUE DEATH AND VASCULAR INVOLVEMENT. THE REPORTER IS REQUESTING A FORMAL REVIEW OF THIS CASE IN CONNECTION WITH THE WEBCOL/CARDINAL HEALTH RECALL RECORDS.