[901027]
Dose knob being difficult to depress and causing bruising (contusion). Case description: this case, (b) (4), is a medical product complaint report from united states referring to a female patient of unknown age. A consumer reported this case. No past medical history, allergies, concurrent conditions or concomitant medications were reported. On an unspecified date (b) (6) 2007, the patient received nutropin aq (dose, route and frequency not reported) for an unreported indication. The lot was n033. The first puncture date of the lot number in question was not reported. The patient's prior history of exposure to lot number in question was not reported. The last dose before the event was not reported. On an unknown date, the patient experienced difficulty with dose knob as it was difficult to depress which cause bruising (bruising). Relevant laboratory tests and treatment information were not reported. It was not reported if the patient continued/discontinued treatment with lot number n033. It was not reported whether the patient switched to another lot number. Action taken with lot number n033 was not reported. At the time of this report, the event outcome was not known. The consumer did not provide an assessment of causality between the event of bruising and the use of nutropin aq or the nutropin aq pen. No other possible etiological factors were reported. This report was forwarded to genentech product quality (b) (4). Additional information has been requested. If received, case will be updated accordingly.
Patient Sequence No: 1, Text Type: D, B5