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 01,02,04 report with the FDA on 2010-02-26 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[18512124] Overdose, headache, pain at injection site [accidental overdose]. Case description: this case, (b)(4), is a solicited report from (b)(6) referring to a (b)(6) female patient. The patient's father reported the event from a company sponsored patient support program for nutropin aq. No past medical history, concurrent illnesses, or allergies were reported. There were no concomitant medications reported. On (b)(6) 2010, the patient initiated nutropin aq (0. 7 mg, frequency not reported, subcutaneous, lot number not reported) via nutropin aq pen (lot number u061) for an unknown indication. This was the only dose prior to the event onset. On the same day, (b)(6) 2010, the patient experienced overdose, headache, pain at injection site (overdose accidental). The patient's father reported that he set the injector to administer 0. 7 mg nutropin aq on the evening of (b)(6) 2010. He stated that the nutropin aq pen malfunctioned and the patient received 3. 5 mg. He reported that he was unable to return the piston to the center of the injector. Relevant laboratory tests and treatment were not reported. There was no action taken with nutropin aq or nutropin aq pen. On the same day, (b)(6) 2010, the event resolved. On (b)(6) 2010, the patient complained of headache and pain at injection site. The patient was given motrin to treat the headache, which resolved the same day. The pain at injection site was reported as persisting. The consumer did not provide a causality assessment of the event overdose accidental in relation to nutropin aq or nutropin aq pen. The consumer noted that the nutropin aq pen malfunctioned. There were no possible etiological factors reported. 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 Number2917293-2010-00004
MDR Report Key1620228
Report Source01,02,04
Date Received2010-02-26
Date of Report2010-02-03
Date Mfgr Received2010-02-03
Date Added to Maude2011-10-18
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 Received2010-02-26
Lot NumberU061
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2010-02-26

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