WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON G55442 J-BGC-015055

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 2019-07-29 for WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON G55442 J-BGC-015055 manufactured by Cook Inc.

MAUDE Entry Details

Report Number1820334-2019-01833
MDR Report Key8837981
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-29
Date of Report2019-09-25
Date of Event2019-07-23
Date Mfgr Received2019-09-25
Device Manufacturer Date2018-10-26
Date Added to Maude2019-07-29
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 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 NameWORD CATHETER SILICONE BARTHOLIN GLAND BALLOON
Generic NameKNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC
Product CodeKNA
Date Received2019-07-29
Returned To Mfg2019-09-12
Model NumberG55442
Catalog NumberJ-BGC-015055
Lot Number9263238
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.