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 2019-03-15 for MYSTIC II,MUSHROOM CUP 10057 manufactured by Coopersurgical, Inc..

Event Text Entries

[139062220] Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[139062221] We try to use suction cup during an emergency cesarean section, the product was not functional. (postponement of the intervention, prolongation of hospitalization, loss of transient function) widespread disorganization, malfunction of the service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2019-00129
MDR Report Key8424635
Date Received2019-03-15
Date of Report2019-03-15
Date of Event2019-03-06
Date Mfgr Received2019-03-06
Device Manufacturer Date2018-07-31
Date Added to Maude2019-03-15
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 Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
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 NameMYSTIC II,MUSHROOM CUP
Generic NameMYSTIC II,MUSHROOM CUP
Product CodeHDB
Date Received2019-03-15
Model Number10057
Catalog Number10057
Lot Number248041
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-15

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