COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-21 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000 manufactured by Cook Inc.

Event Text Entries

[145639022] This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[145639023] It is reported during a sonohysterosalpingography, in vagina cervix and uterus using a cook silicone balloon hysterosalpingography injection catheter, the balloon was impossible to deflate when the procedure was over. It is unknown how the procedure was completed after this issue was experienced. There were no adverse effects to the patient as a result of this alleged product malfunction. No section of the device remained inside the patient's body. The patient did not require any additional procedures as a result of this occurrence. Additional details regarding the patient and the event have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-01163
MDR Report Key8627710
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-21
Date of Report2019-07-03
Date of Event2019-05-02
Date Mfgr Received2019-06-07
Device Manufacturer Date2018-01-26
Date Added to Maude2019-05-21
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 FDA3
Event Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
Generic NameHES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
Product CodeHES
Date Received2019-05-21
Model NumberG17870
Catalog NumberJ-CHSG-703000
Lot Number8539787
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-21

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