SOFT-TRANS EMBRYO TRANSFER CATHETER K-SOFT-5000-MO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-08-11 for SOFT-TRANS EMBRYO TRANSFER CATHETER K-SOFT-5000-MO manufactured by Cook Inc.

Event Text Entries

[82474002] (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[82474003] The user facility reported, the soft-trans embryo transfer catheter was flushed with clear media but the fluid came out yellow. The catheter was not used. As indicated in complaint report, there was no patient injury or death related to this device issue. The device was not used on the patient. Requests have been made for additional patient, product and event detail but response has not been received to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-02304
MDR Report Key6787485
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-08-11
Date of Report2017-11-09
Date of Event2017-08-04
Date Mfgr Received2017-11-09
Date Added to Maude2017-08-11
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOFT-TRANS EMBRYO TRANSFER CATHETER
Generic NameMQF CATHETER, ASSISTED REPRODUCTION
Product CodeMQF
Date Received2017-08-11
Catalog NumberK-SOFT-5000-MO
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-11

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