HERCULES III T401161 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-22 for HERCULES III T401161 N/A manufactured by Terumo Cardiovascular Systems Corporation.

Event Text Entries

[145914229] Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[145914230] The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the hercules collapsed by falling on the myocardium and it was impossible to reposition it correctly, as it has no longer maintained desired position. ? There was a delay for 2 minutes. Product was changed out. Procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1124841-2019-00140
MDR Report Key8634287
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-05-22
Date of Report2019-08-02
Date of Event2019-04-18
Date Mfgr Received2019-07-17
Device Manufacturer Date2018-04-05
Date Added to Maude2019-05-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CATHLEEN HARGREAVES
Manufacturer Street125 BLUE BALL ROAD
Manufacturer CityELKTON MD 21921
Manufacturer CountryUS
Manufacturer Postal21921
Manufacturer Phone8002837866
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHERCULES III
Generic NameUNIVERSAL STABILIZER ARM
Product CodeMSW
Date Received2019-05-22
Returned To Mfg2019-06-20
Model NumberT401161
Catalog NumberN/A
Lot NumberT00706
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address125 BLUE BALL ROAD ELKTON MD 21921 US 21921


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-05-22

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