[1086054]
Injection hurt, hard to push knob of pen, [injection site pain]. Case description: this case, manufacturer control number (b)(4), is a spontaneous report from the (b)(6) referring to a child male patient of unknown age. A consumer, the patient's mother, reported this case. No past medical history, concomitant medications, allergies, or concurrent conditions were reported. On an unspecified date in (b)(6) 2008, the patient started treatment with nutropin aq (0. 8mg, qd, subcutaneous) and nutropin aq pen (dose, frequency and route not reported) for the indication of idiopathic growth hormone deficiency. The nutropin aq lot number was not reported. The nutropin aq pen lot number was reported as b120. The first puncture date of the unknown nutropin aq lot number and nutropin aq pen lot number b120 was not reported. The pt's prior history of exposure to the unknown nutropin aq lot number and nutropin aq pen lot number b120 was not reported. It was not reported whether the patient continued, discontinued or switched to another lot number of nutropin aq. It was reported that the nutropin aq pen was replaced with a new lot number which was also b120. On an unspecified date reported as a "few weeks ago", the patient's mother started noticing that the nutropin aq pen knob was hard to depress causing the patient pain during injections (injection site pain). The injections hurt for two days. Relevant laboratory tests and treatment for the event were not reported. Action taken with nutropin aq was not reported. The nutropin aq pen was replaced. The new lot number of the nutropin aq pen was also b120. The new nutropin aq pen "works fine" and the patient has not had any resistance while using it and patient does not complain of pain anymore. On an unspecified date, the event resolved. The consumer did not provide an assessment of the event injection site pain in relation to nutropin aq and nutropin aq pen. No other possible etiological factors were identified. This report was forwarded to genentech, inc. Product quality and assigned pcs# (b)(4). Additional information is being requested. If received, the case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5