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Patient 1
0N FRIDAY, 1/10/97, CO RECEIVED NOTIFICATION FROM A PHYSICIAN AT CLINIC STATING A PT THAT HAD UNDERGONE AN INTRAUTERINE INSEMINATION (IUI) PROCEDURE ON 12/13/96, HAD EXPERIENCED A REACTION. CO WAS CONTACTED ON FRIDAY, 1/10/97, REGARDING THIS CUSTOMER NOTIFICATION. THE DATE OF THE EVENT WAS FRIDAY, 12/13/96. CO DID NOT RECEIVE COMPLETE INFO REGARDING PRODUCT LOT NUMBER OF OTHER IDENTIFICATION. ON 1/15/97 THE PRODUCT LOT NUMBER WAS OBTAINED FROM THE CUSTOMER. ON 12/13/96, THE PT PRESENTED THE DAY AFTER HER LH SURGE FOR AN INTRAUTERINE INSEMINATION. STANDARD WASH WAS DONE TWICE WITH A SWIM UP AND THE SUPERNATANT FROM THE SWIM UP HAD A COUNT OF 65 MILLION PER MIL, 89% MOTILE SPERM AND WAS DRAWN UP IN A TOMCAT CATHETER AND INTRAUTERINE INSEMINATION WAS DONE WITH THE SWIM UP SPERM. THE PELLET WAS PLACED IN THE CERVIX, AGAIN WITH A TOMCAT CATHETER. IMMEDIATELY AFTER THE INSEMINATION, THE SPECULUM WAS REMOVED AND THE PT BEGAN FEELING SEVERE CRAMPING AND THEN BECAME NAUSEATED. VITAL SIGNS REMAIN STABLE, BUT BECAUSE OF CONTINUED CRAMPING AND NAUSEA, SHE WAS GIVEN SOME SMELLING SALTS AND 400 MILLIGRAMS OF MOTRIN. WITHIN FIVE MINUTES AFTER THE MOTRIN, THE PT DEVELOPED DIFFUSE HIVES AND SWELLING. THROUGHOUT THIS ENTIRE TIME, HER LUNG SOUNDS WERE CLEAR. AT THIS POINT, SHE WAS GIVEN SUB-CUTANEOUS EPINEPHRINE AS WELL AS INTRAMUSCULAR BENADRYL AND WAS THEN TAKEN BY AMBULANCE TO HOSP, WHERE SHE WAS GIVEN SOLU-MEDROL AND OBSERVED OVERNIGHT. SHE NEVER DEVELOPED RESPIRATORY DISTRESS. OF INTEREST IS THAT THE PT HAS A HISTORY OF ASTHMA, MORE SEVERE AS A CHILD, MILD AS AN ADULT AND A HISTORY OF MULTIPLE ALLERGIES TO PENICILLIN, SULFA DRUGS, TETANUS, PEANUTS, POLLEN AND MSG, ALL OF WHICH CAUSE FULL BODY SWELLING. IT IS UNCLEAR EXACTLY WHAT SHE WAS REACTING TO. REPORTS OF TRUE ALLERGY TO SPERM ARE EXTREMELY RARE. IT MAY BE POSSIBLE THAT THE PT WAS ALLERGIC TO THE BOVINE SERUM ALBUMIN USED IN THE MEDIA.