LL100 CRYOSURGICAL 900001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-02-28 for LL100 CRYOSURGICAL 900001 manufactured by Coopersurgical, Inc..

MAUDE Entry Details

Report Number1216677-2020-00061
MDR Report Key9769097
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2020-02-28
Date of Report2020-02-24
Date of Event2019-03-20
Date Mfgr Received2020-02-19
Date Added to Maude2020-02-28
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 ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL, CT
Manufacturer CountryUS
Manufacturer Phone6015200334
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street95 CORPORATE DRIVE
Manufacturer CityTRUMBULL, CT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLL100 CRYOSURGICAL
Generic NameLL100 CRYOSURGICAL
Product CodeGEH
Date Received2020-02-28
Model Number900001
Catalog Number900001
Lot NumberN/A
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL, CT US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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