PRIMEVIEW 3I 7341428

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 2019-07-02 for PRIMEVIEW 3I 7341428 manufactured by Siemens Healthcare Gmbh.

MAUDE Entry Details

Report Number3002466018-2019-85907
MDR Report Key8752534
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-02
Date of Report2019-06-13
Date of Event2019-06-13
Date Mfgr Received2019-06-13
Date Added to Maude2019-07-02
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 ContactREBECCA TUDOR
Manufacturer Street40 LIBERTY BLVD. 65-1A
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6104486484
Manufacturer G1SIEMENS HEALTHCARE GMBH
Manufacturer StreetROENTGENSTRASSE 19-21
Manufacturer CityKEMNATH, 95478
Manufacturer CountryGM
Manufacturer Postal Code95478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRIMEVIEW 3I
Generic NameACCELERATOR, LINEAR, MEDICAL
Product CodeIYE
Date Received2019-07-02
Model Number7341428
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer AddressROENTGENSTRASSE 19-21 KEMNATH, 95478 GM 95478


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-02

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