EMPRINT CA15L2

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 2020-03-25 for EMPRINT CA15L2 manufactured by Covidien Medical Products.

Event Text Entries

[185940067] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185940068] According to the reporter, ablation of chondroblastoma, the antenna broke off in patient after two repositioning within the lesion. There was no resistance experience within the lesion. Imaging was done to locate the tip of the antenna and it was found in the lesion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006451981-2020-00049
MDR Report Key9877283
Report SourceUSER FACILITY
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-25
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 ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityMINNEAPOLIS MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1COVIDIEN MEDICAL PRODUCTS
Manufacturer StreetBUILDING 10- NO 789 PUXING ROA
Manufacturer CitySHANGHAI 201114
Manufacturer CountryCN
Manufacturer Postal Code201114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEMPRINT
Generic NameSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Product CodeNEY
Date Received2020-03-25
Model NumberCA15L2
Catalog NumberCA15L2
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MEDICAL PRODUCTS
Manufacturer AddressBUILDING 10- NO 789 PUXING ROA SHANGHAI 201114 CN 201114


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-25

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