POLYCHROME MEDICAL SC 98202340 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-03 for POLYCHROME MEDICAL SC 98202340 * manufactured by Polychrome Medical.

Event Text Entries

[19890383] Stimulation unit produced blisters on pt's forearm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1028074
MDR Report Key452318
Date Received2003-04-03
Date of Report2003-04-03
Date of Event2003-03-04
Date Added to Maude2003-04-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePOLYCHROME MEDICAL
Generic NameCF INDICATOR
Product CodeKTB
Date Received2003-04-03
Model NumberSC 98202340
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key441308
ManufacturerPOLYCHROME MEDICAL
Manufacturer Address2700 FREEWAY BLVD SUITE 750 BRROKLYN MN 55430 US


Patients

Patient NumberTreatmentOutcomeDate
10 2003-04-03

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