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. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

ON (B)(6) 2026, THE CUSTOMER LEFT A MESSAGE WITH THE FIELD CORRECTION ACTION TEAM STATING THAT SHE RECEIVED A LETTER ABOUT HER ALCOHOL PREPS BEING POSSIBLY ON THE RECALL AND THEN CONFIRMED THAT THEY ARE BECAUSE THE LOT NUMBER MATCHES. SHE STATED SHE GOT AN INFECTION A COUPLE OF DAYS AFTER USING THEM WHICH THEY HAD TO CUT HER OPEN TO DRAIN IT. DURING A CALL BACK ON (B)(6) 2026, THE CUSTOMER STATED THAT SHE DOES IMMUNOGLOBULIN (IGG) THERAPY. SHE CLEANED THE INJECTION SITE WITH THE AFFECTED PREP PADS PRIOR TO STICKING HERSELF WITH THE NEEDLE AND NOT EVEN A DAY OR SO LATER, IT BECAME PUFFY. SHE STATED THE INJECTION SITES TYPICALLY GET PUFFY, BUT THIS SITE STAYED PUFFY WHILE THE OTHER SITES GO DOWN. SHE ALSO STATED THAT THE SITE GOT STREAKS OF RED, WAS HOT AND HARD LIKE A KNOT. SHE CALLED HER DOCTOR AND DID A TELEHEALTH VISIT WITH URGENT CARE. THEY GAVE HER ANTIBIOTICS. THE SITE CONTINUED TO GET WORSE. SHE CALLED HER IMMUNOLOGIST WHO STATED SHE MAY NEED TO GET THE SITE CUT OPENED FOR DRAINAGE. SHE WENT TO AN URGENT CARE FACILITY, AND THEY CUT OPEN THE SITE WITH A SCALPEL, AND LEFT IT OPEN FOR DRAINAGE. SHE RECEIVED A 2ND DOSE OF ANTIBIOTICS. SHE WAS REQUIRED TO PRESS ON THE WOUND TO SQUEEZE OUT THE CONTENTS. SHE REPORTED THAT SHE NOW HAS A SCAR AT THE INJECTION SITE. ABOUT TWO WEEKS AFTER THIS INCIDENT, SHE RECEIVED THE RECALL NOTICE. NAMES OF THE ANTIBIOTICS WAS UNKNOWN AT THE TIME OF THE PHONE CALL BUT WERE REQUESTED VIA EMAIL ALONG WITH PHOTOS OF THE INJECTION SITE.