INTEGUSEAL MICROBIAL SKIN SEALANT 200IN 4

Additional Manufacturer Narrative

(B)(4). THE SAMPLES WERE RECEIVED WITH THE PLUNGER FULLY DEPRESSED. THERE WAS NO EVIDENCE OF CYANOACRYLATE DISPENSING ON THE SPONGE APPLICATOR OR ON THE EXTERIOR OF THE HOUSING. THE SIDE WELDS WERE INTACT WITH NO BULGING. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

Description of Event or Problem

HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2015-00016 FOR THE FIRST REPORT. REFER TO 3011270181-2015-00017 FOR THE SECOND REPORT. A REPORT WAS RECEIVED ALLEGING THAT OVER THE PAST YEAR THERE HAVE BEEN AN INCREASE IN THE NUMBER OF CHEST INFECTIONS. NO SPECIFICS ON THE INFECTIONS WERE PROVIDED NOR THE NUMBER OF OCCURRENCES. THE TIMING OF THE INCREASE CORRESPONDS WITH INTRODUCTION ON THE MICROBIAL SKIN SEALANT PRODUCT INTO OPERATING ROOM. IT WAS REPORTED THAT ONCE IN A WHILE, THE INTEGUSEAL WOULD REMOVE SKIN FROM ELDERLY PATIENTS. EXACT DATE/NUMBER OF OCCURRENCES WAS UNKNOWN. REGARDING THE SKIN REMOVAL, IT WAS IN COMBINATION WITH THE IOBAN BEING REMOVED. THE HEALTHCARE PROFESSIONALS AT THE FACILITY CHANGED THEIR CLINICAL PRACTICES. NO FURTHER INFORMATION HAS BEEN PROVIDED.