IPAS EASYGRIP CANNULAE UNK

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 2010-06-24 for IPAS EASYGRIP CANNULAE UNK manufactured by Womancare Global.

Event Text Entries

[1635914] A pregnant female of unknown age was told by a physician that the fetus was not alive. She contacted an ob/gyn who performed an exam and an ultrasound. He concluded that she was (b)(6) weeks pregnant; however, the fetus was not alive (missed abortion). The physician started performing a uterine evacuation procedure and suspected a perforation, so he stopped the procedure. The patient was experiencing mild lower abdomen pain. The following day she had developed a fever and was referred to another facility. No further information was obtained concerning the outcome.
Patient Sequence No: 1, Text Type: D, B5


[8624429] Womancare global first became aware of this ae on 04/13/2010. Initially it was not clear if our cannulae was used or a competitor. On 05/22/2010, we received confirmation from dr (b)(6) that our device was involved.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008007615-2010-00003
MDR Report Key1736789
Report Source01,05,07
Date Received2010-06-24
Date of Report2010-06-23
Date of Event2010-03-21
Date Mfgr Received2010-05-22
Date Added to Maude2010-06-29
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 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 NameIPAS EASYGRIP CANNULAE
Product CodeHGH
Date Received2010-06-24
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
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. Hospitalization 2010-06-24

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