COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER J-CHSG-503000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER J-CHSG-503000 manufactured by Cook Inc.

Event Text Entries

[129908474] This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10


[129908475] It was reported that twice in the last 2-3 months. During the hysterosalpingogram the silicone hysterosalpingography injection catheter balloon would not deflate when inside the patient. The catheter was able to be pulled out while inflated, nothing detached in the patient. There were no adverse effects reported due to the event and no report of an additional procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-03633
MDR Report Key8133424
Date Received2018-12-05
Date of Report2018-12-05
Date Mfgr Received2018-11-29
Date Added to Maude2018-12-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 Phone8128294891
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 Report0

Device Details

Brand NameCOOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
Generic NameHES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES)
Product CodeHES
Date Received2018-12-05
Model NumberNA
Catalog NumberJ-CHSG-503000
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2018-12-05

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