FBK DUAL INC. W/O TROCAR 8/PK 006889-901

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-05 for FBK DUAL INC. W/O TROCAR 8/PK 006889-901 manufactured by Gyrus Acmi, Inc.

MAUDE Entry Details

Report Number2951238-2020-00354
MDR Report Key9793835
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-05
Date of Report2020-03-27
Date Mfgr Received2020-03-26
Device Manufacturer Date2018-02-28
Date Added to Maude2020-03-05
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 ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFBK DUAL INC. W/O TROCAR 8/PK
Generic NameDISPOSABLE FALOPE-RING BAND
Product CodeKNH
Date Received2020-03-05
Returned To Mfg2020-02-18
Model Number006889-901
Lot NumberMK735611
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC
Manufacturer Address136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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