MOLDEX

Description of Event or Problem

ON (B)(6) 2022, A VERBAL COMPLAINT WAS CALLED IN MOLDEX CUSTOMER SUPPORT BY A USER, (B)(6)(SP?) INDICATING THAT SHE EXPERIENCED AN ALLERGIC REACTION TO LATEX WHEN USING A MOLDEX 2200 N95 RESPIRATOR AND WAS VERY UPSET THAT THERE WAS NO LATEX WARNING ON THE PRODUCT OR PACKAGING. MOLDEX TECHNICAL SERVICES MANAGER, (B)(6) PLACED A RETURN CALL EXPLAINING THE 2200 N95 RESPIRATOR STRAPS DO CONTAIN NATURAL RUBBER LATEX BUT THAT THE RESPIRATOR WAS NOT REQUIRED TO BE NOR MARKETED AS A LATEX FREE PRODUCT. HE OFFERED A REPLACEMENT WITH AN EQUIVALENT 1500 SERIES RESPIRATOR (CLASS 2 MEDICAL DEVICE) THAT IS A LATEX FREE. THE COMPLAINANT WAS NOT INTERESTED IN A REPLACEMENT AND ENDED THE CALL. MOLDEX BELIEVES THAT THE COMPLAINANT RECEIVED THE 2200 N95 THROUGH THE US GOVERNMENT MASS DISTRIBUTION OF N95S TO THE PUBLIC IN (B)(6) 2022 FROM THE STRATEGIC NATIONAL STOCKPILE IN RESPONSE TO THE COVID 19 PANDEMIC. ON (B)(6) 2022, DURING A SCHEDULED SITE INSPECTION, MOLDEX QA WAS ADVISED BY (B)(6), FDA CSO INVESTIGATOR THAT THERE WAS A COMPLAINT MADE TO THE FDA IN (B)(6) 2022 ABOUT AN ALLERGIC REACTION TO LATEX THAT HAD BEEN REPORTED TO MOLDEX BACK IN (B)(6) 2022. FURTHER REVIEW INDICATES THAT THE ABOVE COMPLAINT MATCHES THE COMPLAINT MADE IN (B)(6) 2022 TO THE FDA. THE MOLDEX 2200 N95 RESPIRATOR IS AN INDUSTRIAL MARKET SAFETY DEVICE APPROVED BY NIOSH AND DOES NOT FALL UNDER FDA REGULATIONS NOR MARKETED AS A LATEX-FREE PRODUCT. THE PRODUCT LABELLING AND PACKAGING DO NOT INDICATE THAT THE PRODUCT CONTAINS LATEX MATERIALS. SINCE THE PRODUCT WAS NOT A MEDICAL DEVICE SUBJECT TO FDA OVERSIGHT AND, SINCE IT WAS UNKNOWN TO MOLDEX UNTIL (B)(6) 2022 THAT A COMPLAINT HAD BEEN MADE TO THE FDA SO NO MDR WAS FILED AT THAT TIME. A DECISION WAS MADE BY MOLDEX SR. MANAGEMENT TO ADD A NATURAL RUBBER LATEX CAUTION STATEMENT TO ALL NEW AND AFFECTED PRODUCT PACKAGING TO BE AFFECTIVE ON THE NEXT PACKAGING RE-ORDER POINT. IN ADDITION, AS PART OF AN ON-GOING CONSOLIDATION OF USER INSTRUCTIONS AND WARNINGS AN EQUIVALENT STATEMENT WILL BE MADE AND SUBMITTED TO NIOSH FOR APPROVAL.

Additional Manufacturer Narrative

ON (B)(6) 2022, A VERBAL COMPLAINT WAS CALLED IN MOLDEX CUSTOMER SUPPORT BY A USER, (B)(6) (SP?) INDICATING THAT SHE EXPERIENCED AN ALLERGIC REACTION TO LATEX WHEN USING A MOLDEX 2200 N95 RESPIRATOR AND WAS VERY UPSET THAT THERE WAS NO LATEX WARNING ON THE PRODUCT OR PACKAGING. MOLDEX TECHNICAL SERVICES MANAGER, (B)(6) PLACED A RETURN CALL EXPLAINING THE 2200 N95 RESPIRATOR STRAPS DO CONTAIN NATURAL RUBBER LATEX BUT THAT THE RESPIRATOR WAS NOT REQUIRED TO BE NOR MARKETED AS A LATEX FREE PRODUCT. HE OFFERED A REPLACEMENT WITH AN EQUIVALENT 1500 SERIES RESPIRATOR (CLASS 2 MEDICAL DEVICE) THAT IS A LATEX FREE. THE COMPLAINANT WAS NOT INTERESTED IN A REPLACEMENT AND ENDED THE CALL. MOLDEX BELIEVES THAT THE COMPLAINANT RECEIVED THE 2200 N95 THROUGH THE US GOVERNMENT MASS DISTRIBUTION OF N95S TO THE PUBLIC IN (B)(6) 2022 FROM THE STRATEGIC NATIONAL STOCKPILE IN RESPONSE TO THE COVID 19 PANDEMIC. ON (B)(6) 2022, DURING A SCHEDULED SITE INSPECTION, MOLDEX QA WAS ADVISED BY (B)(6), FDA CSO INVESTIGATOR THAT THERE WAS A COMPLAINT MADE TO THE FDA IN (B)(6) 2022 ABOUT AN ALLERGIC REACTION TO LATEX THAT HAD BEEN REPORTED TO MOLDEX BACK IN (B)(6) 2022. FURTHER REVIEW INDICATES THAT THE ABOVE COMPLAINT MATCHES THE COMPLAINT MADE IN (B)(6) 2022 TO THE FDA. THE MOLDEX 2200 N95 RESPIRATOR IS AN INDUSTRIAL MARKET SAFETY DEVICE APPROVED BY NIOSH AND DOES NOT FALL UNDER FDA REGULATIONS NOR MARKETED AS A LATEX-FREE PRODUCT. THE PRODUCT LABELLING AND PACKAGING DO NOT INDICATE THAT THE PRODUCT CONTAINS LATEX MATERIALS. SINCE THE PRODUCT WAS NOT A MEDICAL DEVICE SUBJECT TO FDA OVERSIGHT AND, SINCE IT WAS UNKNOWN TO MOLDEX UNTIL (B)(6) 2022 THAT A COMPLAINT HAD BEEN MADE TO THE FDA. A DECISION WAS MADE MY MOLDEX SR. MANAGEMENT TO ADD A NATURAL RUBBER LATEX CAUTION STATEMENT TO ALL NEW AND AFFECTED PRODUCT PACKAGING TO BE AFFECTIVE ON THE NEXT PACKAGING RE-ORDER POINT. IN ADDITION, AS PART OF AN ON-GOING CONSOLIDATION OF USER INSTRUCTIONS AND WARNINGS AN EQUIVALENT STATEMENT WILL BE MADE AND SUBMITTED TO NIOSH FOR APPROVAL.