MYSTIC II,MUSHROOM CUP 10057

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for MYSTIC II,MUSHROOM CUP 10057 manufactured by Coopersurgical Inc..

MAUDE Entry Details

Report Number1216677-2018-00047
MDR Report Key8692839
Date Received2019-06-12
Date of Report2019-06-12
Date of Event2018-07-09
Device Manufacturer Date2017-12-08
Date Added to Maude2019-06-12
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 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer StreetCORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMYSTIC II,MUSHROOM CUP
Generic NameMYSTIC II,MUSHROOM CUP
Product CodeHDB
Date Received2019-06-12
Model Number10057
Catalog Number10057
Lot Number230220
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-12

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