FC FEMALE CONDOM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-06-05 for FC FEMALE CONDOM * manufactured by The Female Health Co..

Event Text Entries

[20888195] Customer used female condom and noted outer ring pulled inside vagina during use. Two months later, after suffering a light period in the interim, pt went to see their physician because if "hemmorage". Physician advised that pt had miscarried. Customer has two children.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1422723-2001-00001
MDR Report Key336336
Date Received2001-06-05
Date of Report2001-06-04
Date of Event2001-05-09
Date Added to Maude2001-06-11
Event Key0
Report Source CodeDistributor 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 FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameFC FEMALE CONDOM
Generic NameFEMALE CONDOM BARRIER DEVICE
Product CodeMBU
Date Received2001-06-05
Model Number*
Catalog Number*
Lot Number2447
ID Number*
Device Expiration Date2005-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key325640
ManufacturerTHE FEMALE HEALTH CO.
Manufacturer Address875 N MICHIGAN AVE #3660 CHICAGO IL 60611 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-06-05

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