ALL-FLEX ARCING SPRING DIAPHRAGM UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2010-04-20 for ALL-FLEX ARCING SPRING DIAPHRAGM UNK manufactured by Ortho-mcneil Pharmaceutical Corp.

Event Text Entries

[1524810] Report received from literature. Von mollendorf ce, van damme l, moyes ja, rees vh, callahan mm, mauck ck, et al. Results of a safety and feasibility study of the diaphragm used with acidform gel or ky jelly. Contraception 2010;81:232-239. The pt's medical history, height and weight were unk. The pt was enrolled in a randomized, placebo-controlled safety and feasibility trial of a diaphragm with vaginal gel during 6 months of use among 120 hiv-negative sexually active women. The women received an ortho all-flex arcing spring diaphragm made of natural rubber along with acidform gel for the prevention of pregnancy. No concomitant medications were reported. On an unspecified date the pt became pregnant. The pt outcome was unk. This report is serious (medically significant).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2211100-2010-00006
MDR Report Key1671180
Report Source01,03,05
Date Received2010-04-20
Date of Report2010-04-20
Date Mfgr Received2010-03-16
Date Added to Maude2011-05-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer Street100 TOURNAMENT DRIVE
Manufacturer CityHARSHAM PA 19044
Manufacturer CountryUS
Manufacturer Postal19044
Manufacturer Phone2153257685
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALL-FLEX ARCING SPRING DIAPHRAGM
Generic NameHDW - CONTRACEPTIVE DIAPHRAGM AND ACCESSORIES
Product CodeHDW
Date Received2010-04-20
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerORTHO-MCNEIL PHARMACEUTICAL CORP
Manufacturer AddressRARITAN NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-04-20

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