PHARMANEX *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-05 for PHARMANEX * manufactured by Pharmanex, Inc..

Event Text Entries

[287347] The md believes that the device requires fda approval before marketing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1027583
MDR Report Key443883
Date Received2003-02-05
Date Added to Maude2003-02-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePHARMANEX
Generic NameBIOPHOTONIC SCANNER
Product CodeHCC
Date Received2003-02-05
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key432860
ManufacturerPHARMANEX, INC.
Manufacturer Address10 EAST SOUTH TEMPLE #900 SALT LAKE CITY UT 84133 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-02-05

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