Description of Event or Problem · 1
ON 12/22/97 A DR REC'D A CALL FROM ANOTHER DR REGARDING A POSSIBLE PT REACTION TO IMPREGUM AND PERMADYNE PENTA IMPRESSION MATERIALS. DURING THE APPOINTMENT ON 12/15/97 THE 37 Y/O FEMALE PT HAD THE FOLLOWING PROCEDURES PERFORMED FOLLOWING LOCAL ANESTHESIA WITH 2% LIDOCAINE WITH 1:1000,000 EPINEPHRINE - 1 1/2 CAPSULES: ELECTROSURGICAL CROWN LENGTHENING. POST AND CORE PLACEMENT - DENTATUS POST AND ENCORE BUILDUP CROWN PREPARATION AND PLACEMENT OF RETRACTION CORD WITH THE USE OF HEMODENT FOR TISSUE MANAGEMENT. ONE STEP PRECISION IMPRESSION OF PREPARATION FOR PURPOSE OF FABRICATING CROWN WITH PERMADYNE AND IMPREGUM WITH A QUADRANT TRIPLE TRAY. FABRICATION AND PLACEMENT OF SUPER-T ACRYLIC PROVISIONAL CROWN CEMENTED WITH TEMP, BOND TEMPORARY CEMENT. ON 12/17/97 PT SEEN IN THE SECOND DR OFFICE FOR AN UNSCHEDULED VISIT. THE SECOND DR STATED THAT THE PT COMPLAINED OF REDENSS AND INFLAMMATION TO HER MOUTH. THE SECOND DR NOTED MODERATE REDNESS AND INFLAMMATION TO "AREAS OF THE MOUTH THAT HAD BEEN EXPOSED TO IMPRESSION MATERIAL". 12/18/97 PT CALLED THE SECOND DR'S OFFICE STATING SHE WAS EXPERIENCING BREATHING DIFFICULTIES AND THE SECOND DR ADVISED THAT SHE IMMEDIATELY PROCEED TO THE CLOSEST EMERGENCY ROOM, WHICH SHE THEN DID. AT THE EMERGENCY ROOM SHE WAS TREATED WITH EPINEPHRINE AND SENT HOME WITH A PRESCRIPTION FOR P.O. STEROIDS (PREDNISONE). 12/20/97 THE SECOND DR SAW PT IN OFFICE. THE SECOND DR STATED THAT THE PT'S MOUTH APPEARED TO LOOK AS IT DID ON 12/17/97 AND DID NOT APPEAR TO HAVE WORSENED. 12/22/97 - THE SECOND DR ORIGINALLY NOTIFIED THE FIRST DR AT ESPE AMERICA OF THIS EVENT. INGREDIENT INFO WAS FAXED TO THE SECOND DR'S OFFICE AT THIS TIME FOR PERMADYNE AND IMPREGNUM PENTA. 12/31/97 - A THIRD DR, ESPE, NOTIFIED THE EVENT IN WRITING. 1/5/97 - DURING F/U CALL TO THE SECOND DR'S OFFICE CURT FRIDAY, ESPE WAS NOTIFIED BY THE SECOND DR THAT NO REPORT FROM THE ALLERGIST HAD BEEN REC'D TO DATE. THIRD DR REPORTED THAT AN ADD'L RESPIRATORY EVENT OCCURRED ON 12/29/97 WHICH RETURNED THE PT TO THE EMERGENCY ROOM FOR SIMILAR TREATMENT AS ON 12/18/97. THE SECOND DR STATED THAT SINCE SHE HAD ANOTHER EVENT INDENPENDENT OF EXPOSURE TO IMPRESSION MATERIAL, THIRD DR FELT THAT THE ORIGINAL EVENT IS LIKELY NOT TO BE RELATED TO IMPRESSION MATERIALS USED. 1/14/97-DURING F/U CALL TO THE SECOND DR'S OFFICE, THE DR'S ASSISTANT STATED THAT NO REPORT WAS REC'D BY THE ALLERGIST AND THAT THE PT CANCELED HER APPOINTMENT AND IS STILL WEARING A TEMPORARY CROWN. ANY ADDITIONAL INFO RECEIVED WILL BE FORWARDED TO THE FDA AS DEEMED NECESSARY.