Description of Event or Problem · 1
EVENT VERBATRIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). PAIN, BUMPS AT THE INJECTION SITES [GROWTH RETARDATION] CASE DESCRIPTION: NON-SERIOUS. THIS CASE IS A REPORT FROM A COMPANY SPONSORED SUPPORT PROGRAM IN THE UNITED STATES REFERRING TO A MALE PATIENT. THE PATIENT'S MOTHER PROVIDED THIS REPORT IN RESPONSE TO A CALL FROM A PROGRAM VENDOR. NO PAST MEDICAL HISTORY WAS REPORTED. CONCURRENT CONDITIONS PRESENT AT THE TIME OF THE EVENT INCLUDED AUTISM. NO ALLERGIES WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED METHYLPHENIDATE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE, AND OXCARBAZEPINE. IN 2004, THE PATIENT RECEIVED NUTROPIN AQ, (1.8 MG, QD, SC) FOR THE INDICATION OF PEDIATRIC GROWTH HORMONE DEFICIENCY. THE LOT NUMBER FOR THE PEN DEVICE WAS E902. THE FIRST PUNCTURE DATE OF THE LOT NUMBER IN QUESTION WAS NOT REPORTED. THE PATIENT'S PRIOR HISTORY OF EXPOSURE TO THE LOT NUMBER IN QUESTION WAS NOT REPORTED. THE DATE OF THE LAST ADMINISTRATION PRIOR TO THE ONSET OF THE EVENT WAS NOT REPORTED. IN 2007, THE PATIENT'S MOTHER NOTICED THAT THE PATIENT HAD NOT BEEN GROWING LIKE HE HAD OVER THE PRIOR 2 1/2 YEARS (GROWTH RETARDED). THE PATIENT'S MOTHER STATED THAT IT WAS "POSSIBLE THAT HIS NAQ PEN IS NOT FUNCTIONING PROPERLY". THE PATIENT'S MOTHER ALSO REPORTED THAT EARLY IN HIS THERAPY, SHE USED 29G NEEDLES AND "POSSIBLY HIT HIS THIGH BONE." IT WAS REPORTED THAT THIS CAUSES A LOT OF PAIN. SHE ALSO REPORTED THAT THERE WERE BUMPS AT THE INJECTION SITES. THE REPORTER STATED THAT SHE WAS NOW USING 31G 3/16 INCH NEEDLES WITH PASSIVE NEEDLE SHIELD. NO RELEVANT LABORATORY TESTS OR TREATMENTS FOR THE EVENT WERE REPORTED. NO ACTION WAS TAKEN WITH NUTROPIN AQ. IT WAS REPORTED THAT THE PATIENT CONTINUED TREATMENT WITH THE SAME DEVICE AND WOULD CONTINUE TO USE IT UNTIL A REPLACEMENT ARRIVED. AT THE TIME OF THIS REPORT, THE EVENT REMAINED ONGOING. REPORTS FROM PATIENT SUPPORT PROGRAMS ARE REGARDED AS SOLICITED IN NATURE AND AN IMPLIED CAUSALITY CANNOT BE INFERRED. NO OTHER ETIOLOGIC INFORMATION WAS REPORTED. THIS REPORT WAS FORWARDED TO GENENTECH PRODUCT QUALITY AND ASSIGNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.