Additional Manufacturer Narrative · 1
PER CONTACT WITH THE TREATING PHYSICIAN AND EVENT REPORTER, THE PT WAS TREATED IN A REMOTE REGION OF AFGHANISTAN AND THE SINGLE-USE PACKAGE WAS DISCARDED. THE DEVICE ORIGINATED FROM A SPECIAL FORCES PACK. THE DEVICE IS NOT AVAILABLE FOR EVAL AND THE LOT NUMBER AND DATE CODE WERE NOT RECORDED. THE DEVICE PERFORMED AS INTENDED AND STOPPED TRAUMATIC BLEEDING. NO CHANGE TO THE PRODUCT OR LABELING IS NECESSARY. Z-MEDICAL CORP HAS RECEIVED MEDWATCH REPORT AND WE HAVE COMPLETED OUR INVESTIGATION REGARDING THE ADVERSE EVENT. WE HAVE ENCLOSED FDA FORM 3500A, COMPLETE WITH OUR INFO, AND HAVE ENCLOSED A COPY OF THE CURRENT DEVICE PACKAGING. DURING OUR INVESTIGATION, WE DETERMINED THAT THE DEVICE IN QUESTION AND THE PACKAGE CONTAINING THE DEVICE WAS DISCARDED IN THE FIELD AND WAS NOT AVAILABLE FOR ANALYSIS. THEREFORE, OUR CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP" IS MOST APPROPRIATE. WE CONTACTED THE DR WHO SUBMITTED THE INITIAL MDR AND HE INFORMED US THAT THE PRODUCT HAD BEEN USED ON A SOLDIER IN ANOTHER COUNTRY AND THAT THE DEVICE AND PACKAGE HAD NOT BEEN RETAINED. OUR INVESTIGATION CONFIRMED THAT THE DEVICE PERFORMED AS INTENDED AND STOPPED TRAUMATIC BLEEDING. NO CHANGE TO THE PRODUCT OR LABELING IS NECESSARY. A COMPLAINT FILE REVIEW HAS FOUND THAT THIS MDR IS THE 3RD ADVERSE EVENT REPORTED FOR THE PRODUCT. ALL 3 MDRS FOR THIS DEVICE INVOLVE BURNING INJURIES. QUICKCLOT HAS CONTAINED A BURN/HEAT WARNING SINCE THE PRODUCT WAS CLEARED ON 5/23/02. Z-MEDICAL CORP HAS DEVELOPED A SECOND GENERATION OF COOLER ZEOLITE BASED HEMOSTATS AND THEY WERE CLEARED BY THE FDA ON 7/19/06. THE TWO PRODUCTS, FIRST RESPONSE AND ACS+, ARE FORMULATED TO HAVE THE SAME EFFICACY AS QUICKCLOT, BUT THE PEAK TEMPERATURE IS CONTROLLED TO A MAXIMUM OF 115 DEGREES F.