ACTIVAPATCH IONTOGO 4.0 NC89189

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-20 for ACTIVAPATCH IONTOGO 4.0 NC89189 manufactured by North Coast Medical.

Event Text Entries

[111734341] There is no specific information regarding the injuries such as size, depth, or site beneath electrode. There are no photos of the "burns". The anatomical locations included the hips, knees, shoulders and elbow. The exact number of patients is not stated. The complaint states some patients were treated with ultrasound prior to iontophoresis. Ifu states patients should not be treated with ultrasound prior to iontophoresis. How many of the patients were treated with ultrasound is not stated. The treatment of the burns and the outcome is not stated.
Patient Sequence No: 1, Text Type: N, H10


[111734342] Pt used patches on individual who may have had ultrasound prior to use. After use patient received skin irritation/electrical burn. May have gone to primary care physician for treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000124207-2018-00009
MDR Report Key7621006
Report SourceHEALTH PROFESSIONAL
Date Received2018-06-20
Date of Report2018-06-19
Date of Event2018-01-23
Date Added to Maude2018-06-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICAL THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetNO.48 LANE 392 FU TEH 1ST RD XI HI DIST
Manufacturer CityNEW TAIPEI CITY, TAIWAN CHINA 221
Manufacturer CountryTW
Manufacturer Postal221
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACTIVAPATCH IONTOGO 4.0
Generic NameACTIVAPATCH IONTOGO
Product CodeEGJ
Date Received2018-06-20
Catalog NumberNC89189
Lot NumberBEW161001
OperatorPHYSICAL THERAPIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNORTH COAST MEDICAL
Manufacturer Address780 SUITE 100 JARVIS MORGAN HILL CA 95037 US 95037


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-20

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