NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-07-01 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[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


MAUDE Entry Details

Report Number2917293-2009-00003
MDR Report Key1409840
Report Source04
Date Received2009-07-01
Date of Report2009-06-02
Date Mfgr Received2009-06-02
Date Added to Maude2011-03-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJAMES NICKAS, PHARM D
Manufacturer Street1 DNA WAY
Manufacturer CitySOUTH SAN FRANCISCO CA 94080
Manufacturer CountryUS
Manufacturer Postal94080
Manufacturer Phone6502255591
Manufacturer G1GENENTECH, INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG
Generic NameNONE
Product CodeKZE
Date Received2009-07-01
Lot NumberB120
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2009-07-01

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