MEDITRODE 6570M *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-06 for MEDITRODE 6570M * manufactured by Life Tech International, Inc..

Event Text Entries

[16787709] Pt received iontophoresis treatment utilizing new electrode. Procedure followed according to mfrs instructions. Iontophoresis protocal followed for 1. 5 ma. Pt reported no burning during treatment and skin inspection was negative. The next day pt reported 2 small 3-4 mm blisters on anterior rt shoulder.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012436
MDR Report Key130576
Date Received1997-11-06
Date of Report1997-10-17
Date of Event1997-10-08
Date Added to Maude1997-11-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICAL THERAPIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDITRODE
Generic NameDRUG DELIVERY ELECTRODE
Product CodeKTB
Date Received1997-11-06
Model Number6570M
Catalog Number*
Lot Number3708503
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key127697
ManufacturerLIFE TECH INTERNATIONAL, INC.
Manufacturer Address10920 KINGHURST HOUSTON TX 77099 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-11-06

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