ORTHO SILLICONE ARCING SPRING DIAPHRAGM 65MM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-11 for ORTHO SILLICONE ARCING SPRING DIAPHRAGM 65MM manufactured by Ortho.

Event Text Entries

[15506115] Ortho diaphragms. I have not been able to email ortho to complain directly to them. In (b)(4) due to ortho changing its manufacturing, we can now only get silicone arcing spring diaphragms. They are also not available in smaller sizes. The arcing spring is the most severe and savage type of spring. It is only suitable for use with women who have poor pelvic floor tone and a high pubic arch. I have used a 65 cm flat spring - the most supple and softest spring option - happily for over 23 years. My husband and i have high fertility as a couple and have 3 nearly grown children. The arcing spring digs in and is uncomfortable plus because of good muscle tone it is being deformed and is puckering down when inserted. This will be a problem in (b)(6) and the (b)(6) and (b)(6) everywhere that women who have good pelvic tone and a low pubic arch are still having to use these horrible arcing spring diaphragms. I have already had a dose of candida albicans -thrush- from the sides digging in. Also this last month, i fear that i had a very early stage miscarriage -we always use spermicide as well- due to the poor fit caused by the arcing spring. As i cannot tolerate hormonal contraceptives, i have no other options. Decent diaphragms and caps that don't hurt should always be easily available as a contraceptive option. I do not want further pregnancies at my age. I would have liked to email ortho to describe how their product has not been suitable for me and also to warn them that if they continue to sell it in (b)(6), it needs to come with a warning as it is likely not fit properly in women with good pelvic tone and with low pubic arches, causing thrush and possible pregnancy. I don't know why they went for the harshest spring instead of the lightest. Obviously, the manufacturers don't use diaphragms. Diagnosis or reason for use: prevent pregnancy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5017803
MDR Report Key1876460
Date Received2010-10-11
Date of Report2010-10-11
Date Added to Maude2010-11-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHO SILLICONE ARCING SPRING DIAPHRAGM 65MM
Generic NameDIAPHRAGM
Product CodeHDW
Date Received2010-10-11
Lot NumberA66DAI
Device Expiration Date2014-05-31
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerORTHO


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-10-11

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