FLEXIBLE KARMAN CANNULAE FC4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2010-07-07 for FLEXIBLE KARMAN CANNULAE FC4 manufactured by Womancare Global.

Event Text Entries

[15557700] The woman came to a clinic to terminate her pregnancy. She was at (b) (6) gestation upon examination. During the procedure severe bleeding started. A 10 iu oxytocin given and fluid replacement was done with a pint of ringer lactate. Bleeding stopped, then started again. In the recovery room she was given 10 iu oxytocin, and fluid replacement was done with 1 pint of haemaccel. She was then taken to a referral hospital 15 minutes away. She died within 20 minutes in the referral hospital.
Patient Sequence No: 1, Text Type: D, B5


[15848359] Additional model numbers: fc5, fc6. Additional catalog numbers: fc5, fc6. This report pertains to one event that occurred with the use of the product described in this report connected to the product described in manufacturer report #3008007615-2010-005.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008007615-2010-00004
MDR Report Key1751268
Report Source01,05,07
Date Received2010-07-07
Date of Report2010-07-08
Date of Event2010-05-23
Date Mfgr Received2010-06-11
Date Added to Maude2010-07-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street300 MARKET STREET SUITE 134
Manufacturer CityCHAPEL HILL NC 27516
Manufacturer CountryUS
Manufacturer Postal27516
Manufacturer Phone9194422621
Manufacturer G1PACIFIC HOSPITAL SUPPLY CO.
Manufacturer CityTONG LO
Manufacturer CountryTW
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameFLEXIBLE KARMAN CANNULAE
Product CodeHGH
Date Received2010-07-07
Model NumberFC4
Catalog NumberFC4
Lot NumberUNKNOWN
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWOMANCARE GLOBAL
Manufacturer AddressCHAPEL HILL NC US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2010-07-07

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