CE82 DELIVERY SYSTEM 2000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for CE82 DELIVERY SYSTEM 2000 manufactured by Coopersurgical, Inc..

Event Text Entries

[144962876] Coopersurgical, inc. Is investigating the condition reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[144962877] Unit not working temp problem. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2019-00077
MDR Report Key8603834
Date Received2019-05-13
Date of Report2019-05-13
Date of Event2019-02-01
Date Mfgr Received2019-05-02
Date Added to Maude2019-05-13
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 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 NameCE82 DELIVERY SYSTEM
Generic NameCE82 DELIVERY SYSTEM
Product CodeHQA
Date Received2019-05-13
Model Number2000
Catalog Number2000
Lot Number058904
OperatorHEALTH PROFESSIONAL
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 2019-05-13

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