HENRY SCHEIN SOFTLINE CHAIRSIDE RELINE KIT

Additional Manufacturer Narrative

THIS PRODUCT HAS BEEN USED IN DENTISTRY FOR MANY YEARS. TO DATE, WE HAVE NEVER HAD ANOTHER COMPLAINT OR REPORT OF BLOOD PRESSURE COMPLICATIONS ASSOCIATED WITH THIS PRODUCT. THE CUSTOMER, (B)(6), INDICATED THAT "NO PRODUCT IS BEING RETURNED FOR EVALUATION". AS OF THE DATE OF SUBMISSION OF THIS REPORT, NO SAMPLES OF THE SUSPECT PRODUCT HAD BEEN RECEIVED AND THE LOT NUMBER OF THE PRODUCT IN QUESTION COULD NOT BE DETERMINED. DR. (B)(6), WAS CONSULTED. HE WAS UNAWARE OF ANY SUCH HYPERTENSION RESPONSE FROM DENTAL APPLICATIONS OF THIS MATERIAL.

Description of Event or Problem

ACCORDING TO (B)(6), OFFICE MANAGER FOR (B)(6), A FEMALE PATIENT EXPERIENCED A SUDDEN RISE IN BLOOD PRESSURE WHILE THE RELINE MATERIAL WAS BEING USED AND WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. THEY ADMINISTERED THE PRODUCT AND AFTER ABOUT A MINUTE, SHE COMPLAINED OF BEING DIZZY - THEY GAVE HER SOME WATER AND SHE FELT BETTER - THEY STARTED AGAIN AND AGAIN SHE WAS DIZZY - THE BLOOD PRESSURE READINGS TAKEN WERE 201/138; 217/121; AND 217/143. SHE GAVE THEM PERMISSION TO CALL AN AMBULANCE AND HAVE HER TRANSPORTED TO THE HOSPITAL WHERE SHE WAS ADMITTED. THEY SPOKE TO HER A FEW DAYS LATER AND ADVISED HER TO SEE AN ALLERGIST TO FIND OUT WHAT CAUSED THIS RISE IN BLOOD PRESSURE, BUT SHE REFUSED STATING "WHO IS GOING TO PAY FOR THIS? I CANNOT AFFORD TO GO TO ANOTHER DOCTOR." THEY REQUESTED THE TRANSCRIPTS FROM THE HOSPITAL, BUT SHE REFUSED TO SIGN THE RELEASE. THIS WAS THE FIRST TIME THIS PRODUCT WAS USED ON HER. THEY USE IT EVERY DAY ON OTHER PATIENTS AND HAVE HAD NO PROBLEM. THE BOX AND PRODUCT WAS GIVEN TO THE EMS SO THE LOT CODE IS NOT AVAILABLE. HE WILL RECORD LOT NUMBERS IN THE FUTURE.