[15614279]
Redness around the site, knot under side, soreness [injection site nodule]. Case description: this case, mfr control number (b)(4), is a solicited report from the (b)(6) referring to a (b)(6) female pt. The pt's mother reported the event to a genentech sponsored pt support program for somatropin. No past medical history, concurrent illnesses, allergies, or concomitant medications were reported. On an unspecified date in (b)(6) 2008, the pt commenced treatment with somatropin (0. 8 mg, qd, subcutaneous) and somatropin pen for the indication of growth hormone deficiency. The last dose prior to the onset of the event was not reported. On (b)(6) 2009, the pt developed redness around the site, knot under the site (injection site nodule), and soreness after receiving treatment with somatropin aq 20mg cartridge, lot 735670. The first puncture date was not reported, however, it was reported that the pt received a total of 4 injections from this lot and experienced 4 reactions after each administration. Approx 10-16 hrs after each injection, the reaction would subside. It was noted that the pt had not experienced these reactions in the past. The pt's prior history of exposure to the lot number in question was not reported. No relevant laboratory tests were performed. Treatment for the event was not reported. The mother contacted the prescribing physician, who instructed her to not use the cartridge in question and contact genentech for a replacement as they had no medication on hand. Treatments with somatropin and somatropin pen were discontinued. It was further noted that the pt's mother was drawing up the medication into regular syringes immediately prior to use, as the pt was afraid to use the somatropin pen. On (b)(6) 2009, the event resolved. The event was identified as medically significant by the reporter. The consumer assessed the vent injection site nodule as not applicable to somatropin and somatropin pen. No other possible etiological factors were reported. This report was forwarded to genentech product quality and assigned (b)(4). No further info was expected.
Patient Sequence No: 1, Text Type: D, B5