SUMAVEL DOSEPRO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-05 for SUMAVEL DOSEPRO manufactured by Zogenix.

Event Text Entries

[18914086] Following use of sumavel dosepro i had slight echo problem in the right ear. I again used the sumavel on wednesday, (b)(6). Several hours later i lost the hearing in my right ear. I read the info sheet on the medication and it indicated there were ear problems in the trials. The doctor has told me i have total loss of hearing and can see no reasons why. Could you give me additional info regarding the loss of hearing during the trial usage? Dose or amount: one dose, once a day, as needed. Dates of use: #1: (b)(6) 2010; #2: (b)(6) 2010. Diagnosis or reason for use: migraine headaches. Sumavel dosepro used two doses (b)(6), (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5016626
MDR Report Key1750179
Date Received2010-07-05
Date of Report2010-07-05
Date of Event2010-06-20
Date Added to Maude2010-07-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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
Generic Name6MG/ 0.5-ML NEEDLE-FREE DELIVERY SYSTEM
Product CodeKZE
Date Received2010-07-05
Lot Number109381
Device Expiration Date2010-10-01
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerZOGENIX


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-07-05

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