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 02,04 report with the FDA on 2009-04-09 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[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


MAUDE Entry Details

Report Number2917293-2009-00002
MDR Report Key1397994
Report Source02,04
Date Received2009-04-09
Date of Report2009-03-10
Date Mfgr Received2009-03-10
Date Added to Maude2011-03-21
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
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 Received2009-04-09
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-04-09

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