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 2009-04-06 for NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG manufactured by Genentech, Inc..

Event Text Entries

[1069111] Excessive pain [pain]. Case description: this case, manufacturer control number (b)(4), is a spontaneous report from the (b)(6) referring to an (b)(6) male patient. The patient's mother reported this case. Past medical history included treatment with norditropin. No concurrent illness, allergies or concomitant medications were reported. On (b)(6)-2009, the patient started treatment with nutropin aq (1. 7 mg, qpm, route not reported ) and nutropin aq pen (dose, frequency and route not reported) for the indication of growth retardation. The lot number for nutropin aq was reported as 708128. The lot number for nutropin aq pen was not reported. This was the only dose administered prior to the onset of the event. The patient had no prior history of exposure to lot number 708128. The first puncture date of lot number 708128 was reported as (b)(6)-2009. On (b)(6)-2009, the patient presented with excessive pain (pain). It was reported that the nutropin aq pen, when ejected, is very stiff, causing excessive pain to the patient. There was a "stinging sensation-likely because of the size of the needle". It was also reported that the nutropin aq pen injects better with the "pink needles but it is a lot longer than the blue needles that he was originally using". When the patient used the blue needle, "it was very hard to inject the medication with the plunger thereby causing more pain". The butt was the specific body location affected by the event. Relevant laboratory tests were not reported. Treatment for the event was reported as changing the needle size. "the plunger worked better, but size of needle causes pain. The other smaller needle caused the plunger to be really stiff and hard to inject". The patient continued use with nutropin aq pen and the patient did not need a replacement. Action taken with nutropin aq was not reported. It was not reported whether the patient continued or discontinued use with nutropin aq lot number 708128. It was not reported whether the patient switched to another lot number. On an unspecified date, the event improved when the reporter was advised to use the larger needle. It was reported that no sample will be returned. The consumer assessed the event pain as related to the "poor design" or nutropin aq pen. The consumer did not provide an assessment of the event pain in relation to nutropin aq. No other possible etiological factors were identified. This report was forwarded to genentech product quality and assigned pcs# (b)(4). No further information is expected. Pharmacovigilance: pain at the injection site is labeled per (b)(4)for somatropin and somatropin pen and expected per ib. Potential contributing factors include the needle size. However, the possibility that somatropin contributed to the event cannot be excluded.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2917293-2009-00001
MDR Report Key1357445
Report Source04
Date Received2009-04-06
Date of Report2009-03-06
Date Mfgr Received2009-03-06
Date Added to Maude2011-03-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Received2009-04-06
Lot NumberNOT REPORTED
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2009-04-06

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