TODAY SPONGE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-30 for TODAY SPONGE manufactured by .

Event Text Entries

[20622686] The today sponge contains nonoxynol-9. Why is the nonxynol-9 still on the market? It increases chance of urinary tract infections, which i have, stds, and even hiv. Can we please enforce a better suited spermicide or require warning labels please? : dates of use: two days. Diagnosis or reason for use: contraceptive. Event abated after use: yes. Event reappeared after introduction: no. Dose or ammount: 1000 mg, frequency: 1 use, route: vag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5002904
MDR Report Key874974
Date Received2007-06-30
Date of Report2007-06-30
Date of Event2007-06-30
Date Added to Maude2007-07-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTODAY SPONGE
Generic NameCONTRACEPTIVE SPONGE
Product CodeLLR
Date Received2007-06-30
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key861282


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2007-06-30

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