MITYONE MUSHROOM CUP 10067

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-05 for MITYONE MUSHROOM CUP 10067 manufactured by Coopersurgical Inc..

MAUDE Entry Details

Report Number1216677-2019-00194
MDR Report Key8764746
Date Received2019-07-05
Date of Report2019-07-05
Date of Event2019-03-16
Date Added to Maude2019-07-05
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 ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMITYONE MUSHROOM CUP
Generic NameMITYONE MUSHROOM CUP
Product CodeHDB
Date Received2019-07-05
Model Number10067
Catalog Number10067
Lot Number243759
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.