HYGENIC FLEXI DAM NON-LATEX PURPLE

Additional Manufacturer Narrative

INVESTIGATION: THE CUSTOMER STATES THEY RECEIVED ONE BOX OF NON-LATEX DENTAL DAM (H09945), LOT UNKNOWN (NOT PROVIDED). THE CUSTOMER STATES THAT A PATIENT HAD AN ALLERGIC REACTION TO THE NON-LATEX DENTAL DAM. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY ANALYSIS SHOWS ZERO ADDITIONAL COMPLAINTS OF CAUSING ALLERGIC REACTIONS IN THE PAST YEAR. TESTING COULD NOT BE PERFORMED DUE TO THE FACT THAT NO PRODUCT WAS RETURNED. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. ROOT CAUSE: 1. PATIENT SENSITIVITY TO A COMPONENT IN THE NON-LATEX DENTAL DAM. 2. SUPPLIER MANUFACTURING ISSUE. 3. PATIENT WAS ALLERGIC/SENSITIVE TO ANOTHER MATERIAL USED DURING THE PROCEDURE. CAPA NOT REQUIRED AT THIS TIME. THIS IS AN ISOLATED AND THIS LOT WILL CONTINUE TO BE MONITORED FOR FURTHER OCCURRENCES. NOTE: THE CUSTOMER STATED ON 02/04/2020 THAT THEY DO NOT BELIEVE THE DENTAL DAM CAUSED THE ALLERGIC REACTION. THEY ARE A LATEX-FREE OFFICE AND HAVE NEVER SEEN THIS TYPE OF REACTION IN 25 YEARS. THE CUSTOMER STATED THAT PATIENT WAS UNDERGOING A ROOT CANAL PROCEDURE AND THEY BELIEVE THAT THE SODIUM HYPOCHLORITE OR OTHER SOLUTION MAY HAVE CAUSED THE REACTION. THE CUSTOMER RECEIVED BENADRYL FROM THE DENTIST AND THE PROCEDURE WAS COMPLETED THE SAME DAY.

Description of Event or Problem

DURING A DENTAL PROCEDURE THE PRODUCT LISTED AND OTHERS WERE USED ON AN ADULT MALE. AN HOUR INTO THE PROCEDURE THE ADULT MALE DEVELOPED ITCHING AND HIVES. IMMEDIATELY THE DENTIST STOPPED THE PROCEDURE AND ADMINISTERED A BENADRYL SHOT. AT THIS TIME THE ADULT MALE IS HOME AND IN CONTACT WITH THE DENTIST TO FIGURE OUT WHAT PRODUCT WAS USED DURING THE PROCEDURE.