PIVET GUIDE EMBRYO TRANSFER SET G30457 K-PETS-5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2019-01-14 for PIVET GUIDE EMBRYO TRANSFER SET G30457 K-PETS-5000 manufactured by Cook Inc.

Event Text Entries

[133330738] (b)(6). 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


[133330739] It was reported that during an embryo transfer procedure using a pivet guide embryo transfer set, and unknown oily liquid was found in the inner catheter when using it to absorb the embryo. The inner catheter was flushed, and the oily liquid was still present after flushing. It is unknown how the procedure was completed after this difficulty. No adverse events have been reported as a result of the alleged malfunction. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2019-00042
MDR Report Key8243860
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2019-01-14
Date of Report2019-09-24
Date of Event2019-01-07
Date Mfgr Received2019-09-20
Device Manufacturer Date2018-08-22
Date Added to Maude2019-01-14
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 NamePIVET GUIDE EMBRYO TRANSFER SET
Generic NameMQF CATHETER, ASSISTED REPRODUCTION
Product CodeMQF
Date Received2019-01-14
Returned To Mfg2019-01-31
Model NumberG30457
Catalog NumberK-PETS-5000
Lot Number9016330
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 2019-01-14

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