IOMED *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-04 for IOMED * manufactured by Iomed, Inc..

Event Text Entries

[18144487] Iontophoresis to left forearm. Pt reported discomfort at 4. 0ma. Decreased to 2. 0ma. After treatment noted a dark blister approx 1 cm diameter. The next day area appeared as grayish looking. Two days later there was a pus pocket with red ring around. Individual sent to er for treatment of infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026072
MDR Report Key415273
Date Received2002-09-04
Date of Report2002-09-04
Date of Event2002-07-30
Date Added to Maude2002-09-11
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 NameIOMED
Generic NameIONTOPHORESIS
Product CodeKTB
Date Received2002-09-04
Returned To Mfg2002-08-02
Model Number*
Catalog Number*
Lot NumberF07388
ID Number5060004: 5000022
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key404310
ManufacturerIOMED, INC.
Manufacturer Address2441 SOUTH 3850 WEST, STE A SALT LAKE CITY UT 841209941 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-09-04

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