NUTROPIN AQ PEN UNK

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 2008-07-11 for NUTROPIN AQ PEN UNK manufactured by Genentech, Inc..

Event Text Entries

[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


MAUDE Entry Details

Report Number2917293-2008-00004
MDR Report Key1074739
Report Source04
Date Received2008-07-11
Date of Report2008-06-11
Date Mfgr Received2008-06-11
Date Added to Maude2010-04-23
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 FDA3
Event Location0
Manufacturer ContactJAMES NICKAS, PHARM.D
Manufacturer Street1 DNA WAY
Manufacturer CitySOUTH SAN FRANCISCO CA 940804990
Manufacturer CountryUS
Manufacturer Postal940804990
Manufacturer Phone6502255591
Manufacturer G1GENENTECH, INC.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUTROPIN AQ PEN
Generic NameNONE
Product CodeKZE
Date Received2008-07-11
Model NumberUNK
Catalog NumberUNK
Lot NumberN033
ID NumberUNK
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENENTECH, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2008-07-11

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