PHORESOR II PM 700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-16 for PHORESOR II PM 700 manufactured by Iomed, Inc..

Event Text Entries

[19626] Pt received small circular burn as a result of the iontophoreic treatment. The burn has caused secondary to the electrode contact with the skin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number29865
MDR Report Key29865
Date Received1996-01-16
Date of Report1996-01-12
Date of Event1995-12-01
Date Facility Aware1995-12-01
Report Date1996-01-12
Date Reported to Mfgr1995-12-15
Date Added to Maude1996-02-12
Event Key0
Report Source CodeUser Facility 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 FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePHORESOR II
Generic NameIONTOPHERESIS DEVICE
Product CodeKTB
Date Received1996-01-16
Returned To Mfg1995-12-27
Model NumberPM 700
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age1.5 YR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key30946
ManufacturerIOMED, INC.
Manufacturer Address1290 W 2320 SOUTH SALT LAKE CITY UT 84119 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1996-01-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.