SUMAVEL DOSEPRO 6 MG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-11 for SUMAVEL DOSEPRO 6 MG manufactured by Zogenix.

Event Text Entries

[2025287] (b)(6) - pt came in with a migraine. Asked to be given above product. It was primed and placed against the skin. It did not activate, so it was tried two more times. At this point, i pulled it away from the pt and within 3 seconds, it self-actuated, forcefully discharging contents into the air. It did not strike the pt or myself but was between both of us as it was being moved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5020575
MDR Report Key2089925
Date Received2011-05-11
Date of Report2011-05-05
Date of Event2011-05-05
Date Added to Maude2011-05-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSUMAVEL DOSEPRO 6 MG
Generic NameTRANSDERMAL
Product CodeKZE
Date Received2011-05-11
Lot Number020688
Device Expiration Date2012-02-01
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerZOGENIX


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-05-11

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