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.

Additional Manufacturer Narrative

H6 HEALTH EFFECT - CLINICAL CODE APPROPRIATE TERM / CODE NOT AVAILABLE WAS USED FOR THE ALLEGATION OF DISCITIS. 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'S HUSBAND HAS RHEUMATOID ARTHRITIS (SINCE 2009) AND TAKES BIWEEKLY ACTEMRA INJECTIONS WHICH HE RECEIVES FROM (B)(6) HOSPITAL SPECIALTY PHARMACY IN (REDACTED BY FDA). HIS MEDICATIONS ARRIVE WITH WEBCOL LARGE ALCOHOL PREP PADS TO CLEAN THE SKIN PRIOR TO INJECTION. HIS LAST USE OF THE WEBCOL ALCOHOL PAD WAS (REDACTED BY FDA) 2026 WITH HIS ACTEMRA INJECTION. HE EXPERIENCED SUDDEN EXCRUCIATING BACK PAIN ON (REDACTED BY FDA) 2026. HE WAS URGENTLY ADMITTED TO THE (REDACTED BY FDA) CLINIC FOUNDATION AND DIAGNOSED WITH BACTEREMIA, OSTEOMYELITIS, DISCITIS, SPINAL AND PSOAS MUSCLE ABSCESS. ON (REDACTED BY FDA) 2026, THE REPORTER RECEIVED AN EMAIL FROM (B)(6) HOSPITAL SPECIALTY PHARMACY WHILE SITTING BEDSIDE WITH HER HUSBAND IN CRITICAL CONDITION THAT THE FDA RECALLED THE WEBCOL ALCOHOL PREP PADS AND THEY SHOULD "DISPOSE OF THEM IMMEDIATELY AND DO NOT USE THEM." HER HUSBAND HAS HAD MULTIPLE BLOOD TESTS SHOWING BACTEREMIA AND SEPSIS LACTATE. REASON FOR USE: TO CLEAN SKIN AREA PRIOR TO INJECTIONS OF ACTEMRA. THE FDA RECALL ANNOUNCEMENT WAS ATTACHED TO THEIR EMAIL. THE REPORTER'S HUSBAND'S SYMPTOMS STARTED ON (REDACTED BY FDA) 2026 AND HE WAS ADMITTED TO (REDACTED BY FDA) ON (REDACTED BY FDA) 2026 WITH THE DIAGNOSES LISTED ABOVE. THE REPORTER WAS BEDSIDE WITH HER HUSBAND WHEN IT WAS RECOMMENDED THAT SHE SUBMIT TO FDA HIS DIAGNOSIS AS HE WAS A REGULAR USER OF THE WEBCOL ALCOHOL PADS, WHICH HAVE BEEN RECALLED FOR MICROBIAL CONTAMINATION AND POSSIBILITY OF CAUSING BACTEREMIA AND CENTRAL NERVOUS SYSTEM INFECTIONS. SHE WAS GOING OFF OF MEMORY AND FATIGUE WHEN SHE LISTED THE DATES LAST USED ON HER (REDACTED BY FDA) FORM TO FDA. SHE WAS STAYING AT THE HOSPITAL AROUND THE CLOCK AND DID NOT HAVE THEIR LOG OF HIS INJECTION DATES (WHEN HE ALSO USED THE ALCOHOL PADS.) SHE HAVE SINCE BEEN ABLE GO HOME AND LOOKED AT THEIR LOG OF HIS LAST FEW ACTEMRA INJECTIONS AND USE OF THE ALCOHOL PADS. HE HAS USED THE ALCOHOL PADS BIWEEKLY SINCE APPROX. (REDACTED BY FDA) 2021 AND HIS LAST THREE USES WERE ON (REDACTED BY FDA) 2026. SELF INJECTING.