Description of Event or Problem · 1
PENTAX MEDICAL WAS MADE AWARE OF AN ADVERSE EVENT ON (B)(6) 2021 THAT OCCURRED IN THE UNITED STATES. THE REPORTED COMPLAINT WAS THAT THE IT WAS RECENTLY DETERMINED BY HIS HEALTHCARE TEAM THAT HE HAS/HAD AN ALLERGIC REACTION TO THEIR REPROCESSING AGENT. THE ENDOSCOPE MODEL AND SERIAL NUMBER WERE NOT PROVIDED, SO A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED ON 25-JUN-2021 VIA PHONE, BUT THE FACILITY PREFERRED NOT TO PROVIDE ANY ADDITIONAL INFORMATION VERBALLY. A WRITTEN REQUEST VIA EMAIL WAS ALSO SENT, BUT THE RESPONSE HAS NOT BEEN PROVIDED. ALTHOUGH THE PRODUCT CODE HAS NOT BEEN ESTABLISHED AS THE PRODUCT MODEL REMAINS UNKNOWN, PRODUCT CODE EOB IS BEING SELECTED TO SUBMIT THE MDR AND WILL BE UPDATED ON A FOLLOW UP SUPPLEMENTAL REPORT ONCE THE ADDITIONAL INFORMATION IS RECEIVED. THE INVESTIGATION IS IN-PROCESS.