ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH R57422

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for ROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH R57422 manufactured by Rocket Medical Plc.

Event Text Entries

[180889795] Balloon on hsg catheter failed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093207
MDR Report Key9744638
Date Received2020-02-21
Date of Report2020-02-19
Date of Event2020-02-12
Date Added to Maude2020-02-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameROCKET MEDICAL 5FGHSG SONOHYSTOGRAM CATH
Generic NameCANNULA, MANIPULATOR/INJECTOR, UTERINE
Product CodeLKF
Date Received2020-02-21
Model NumberR57422
Lot Number480661
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerROCKET MEDICAL PLC
Manufacturer AddressHINGHAM MA 02043 US 02043


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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