TRUCLEAR 72204879

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 2020-01-30 for TRUCLEAR 72204879 manufactured by Covidien Mansfield.

Event Text Entries

[176999415] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[176999416] According to the reporter, prior to use, the device had a burr on tip and there was an error. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2020-00005
MDR Report Key9647610
Report SourceUSER FACILITY
Date Received2020-01-30
Date of Report2020-03-25
Date of Event2020-01-17
Date Mfgr Received2020-03-09
Date Added to Maude2020-01-30
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 ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MANSFIELD
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUCLEAR
Generic NameHYSTEROSCOPE (AND ACCESSORIES)
Product CodeHIH
Date Received2020-01-30
Returned To Mfg2020-02-10
Model Number72204879
Catalog Number72204879
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MANSFIELD
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

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