GOLDSTEIN SONOHYSTEROGRAPHY CATHETER N/A J-GSHC-523620

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-02 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER N/A J-GSHC-523620 manufactured by Cook Inc.

Event Text Entries

[37336160] (b)(4). Event is still under investigation at this time.
Patient Sequence No: 1, Text Type: N, H10


[37336161] At the end of an unknown procedure on a female patient of unknown age, the user was holding the catheter with swabs while removing the device. The rubber stopper slid off of the catheter in the patient. The physician was able to extricate the part from the patient. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


[49428849] (b)(4). Investigation/evaluation during the course of the investigation, a review of the complaint history, quality control, instructions for use (ifu), and drawing of the product was conducted. The silicone positioner is checked to be at the correct location and the o. D. Of the positioner is checked per qc specifications. The product was not returned for a physical examination; however, it is stated within the provided ifu "upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps. " during the procedure should the positioner fall off of the catheter, the end user is instructed to remove the separated section with forceps. Based on the information provided and the results of our investigation, it is possible that force was applied; which may have resulted in the difficulty experienced. We will continue to monitor for similar complaints. Per the risk assessment (ra) no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[49428850] At the end of an unknown procedure on a female patient of unknown age, the user was holding the catheter with swabs while removing the device. The rubber stopper slid off of the catheter in the patient. The physician was able to extricate the part from the patient. The customer stated it seemed there was not enough resistance for the rubber piece to stay on the device when removing. The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2016-00041
MDR Report Key5403684
Report SourceUSER FACILITY
Date Received2016-02-02
Date of Report2016-01-08
Date of Event2016-01-08
Date Facility Aware2016-01-08
Date Mfgr Received2016-01-11
Date Added to Maude2016-02-02
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 ContactMRS. RITA HARDEN
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8128294891
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGOLDSTEIN SONOHYSTEROGRAPHY CATHETER
Generic NameHFF ASPIRATOR, ENDOMETRIAL
Product CodeHFF
Date Received2016-02-02
Model NumberN/A
Catalog NumberJ-GSHC-523620
ID NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Required No Informationntervention 2016-02-02

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