Description of Event or Problem · 1
PAIN AT INJECTION SITE, MEDICATION LEAKING FROM CARTRIDGE/NEEDLE [INJECTION SITE PAIN]. CASE DESCRIPTION: THIS CASE, (B)(4), IS A SPONTANEOUS REPORT FROM THE UNITED STATES REFERRING TO A MALE PATIENT (AGE NOT REPORTED). THE PATIENT'S RELATIVE REPORTED THIS CASE. CONCURRENT CONDITIONS PRESENT AT THE TIME OF THE EVENT INCLUDED SCOLIOSIS. NO PAST MEDICAL HISTORY, CONCOMITANT MEDICATIONS, OR ALLERGIES WERE REPORTED. ON A DATE NOT REPORTED, "(B)(6) AGO", THE PATIENT RECEIVED NUTROPIN AQ, ("2.2 MG ALTERNATING WITH 2.4 MG", QD SUBCUTANEOUS) VIA NUTROPIN AQ PEN, FOR THE INDICATION OF GROWTH HORMONE DEFICIENCY. THE LOT NUMBERS FOR NUTROPIN AQ AND THE NUTROPIN AQ PEN WERE UNKNOWN. THE FIRST PUNCTURE DATE WAS NOT REPORTED. THE PATIENT'S PRIOR HISTORY OF EXPOSURE TO THE UNKNOWN LOT NUMBERS WAS NOT REPORTED. THIS WAS THE ONLY DOSE OF NUTROPIN AQ ADMINISTERED WITH THE NUTROPIN AQ PEN PRIOR TO THE EVENT. ON A DATE NOT REPORTED, "(B)(6) AGO", THE PATIENT PRESENTED WITH PAIN AT INJECTION SITE, MEDICATION LEAKING FROM CARTRIDGE/NEEDLE (PAIN INJECTION SITE). THE PATIENT WAS UNSURE IF HE RECEIVED THE FULL DOSE DUE TO THE LEAKING CARTRIDGE, AND THE PATIENT ROTATED INJECTION SITES ON HIS LEGS. NO RELEVANT LABORATORY TESTS OR TREATMENT WERE REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT CONTINUED OR DISCONTINUED USE WITH THE UNKNOWN LOT NUMBERS. IT WAS NOT REPORTED WHETHER THE PATIENT SWITCHED TO ANOTHER LOT NUMBER. ACTION TAKEN WITH NUTROPIN AQ AND NUTROPIN AQ PEN IN RESPONSE TO THE EVENT WAS NOT REPORTED. THE EVENT OUTCOME WAS NOT REPORTED. THE PATIENT'S RELATIVE ASSESSED THE EVENT PAIN INJECTION SITE AS RELATED TO NUTROPIN AQ AND THE NUTROPIN AQ PEN BECAUSE THE PATIENT HAD NOT EXPERIENCED PAIN WITH THE PREVIOUS BRAND OF GROWTH HORMONE. NO OTHER POSSIBLE ETIOLOGICAL FACTORS WERE REPORTED. THIS EVENT WAS FORWARDED TO GENENTECH PRODUCT QUALITY AND ASSIGNED THE (B)(4). ADDITIONAL INFORMATION IS BEING REQUESTED. IF RECEIVED, THE CASE WILL BE UPDATED ACCORDINGLY.