UNK FENIX MAGNETIC IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-23 for UNK FENIX MAGNETIC IMPLANT manufactured by Torax Medical, Inc..

MAUDE Entry Details

Report Number3008766073-2019-00396
MDR Report Key8817488
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-23
Date of Report2019-07-08
Date Mfgr Received2019-08-08
Date Added to Maude2019-07-23
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 ContactMILT GARRETT
Manufacturer Street4188 LEXINGTON AVENUE NORTH
Manufacturer CitySHOREVIEW MN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK FENIX MAGNETIC IMPLANT
Generic NameIMPLANTED FECAL INCONTINENCE DEVICE
Product CodePMH
Date Received2019-07-23
Catalog NumberUNK FENIX MAGNETIC IMPLANT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTORAX MEDICAL, INC.
Manufacturer Address4188 LEXINGTON AVENUE NORTH SHOREVIEW MN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-23

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