ActivaPatch IontoGo 4.0 001-50Recalls & reported problems

Activatek Inc. · ActivaPatch IontoGo 4.0 carton with 6 pouches. 4 hour iontophoresis delivery. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859975005202), received between May 11, 2017 and May 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Partial thickness (Second Degree) Burn1
Wound Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryMay 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
PER CUSTOMER, "UTILIZED IONTO PATCH COUPLED WITH DEXAMETHASONE AT THE END OF TREATMENT. SKIN CLEANED WITH ALCOHOL SWAB AND PATCH APPLIED WITHOUT ANY NEED FOR TAPING, ADHERED WELL. PT INSTRUCTED TO LEAVE PATCH ON 4 HRS. SHE NOTED BURNS AFTER REMOVAL." ALSO, PATIENT WAS "INSTRUCTED TO CLEAN BURNS (B)(6) 2017 AND APPLY NEOSPORIN. PATIENT FOLLOWED UP WITH PCP TUESDAY AND IS BEING TREATED FOR INFECTION WITH ANTIBIOTICS."
Patient problems: Partial thickness (Second Degree) Burn; Wound Infection
MAUDE report 6562011 ↗

Device details

UDI-DI	`00859975005202`
Brand	ActivaPatch IontoGo 4.0
Model	001-50
Catalog no.	NC89189
Company	Activatek Inc.
Product code	EGJ · Device, Iontophoresis, Other Uses
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Mar 29, 2018

Device type (GMDN): Drug-delivery iontophoresis patch

A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Other Device, Iontophoresis, Other Uses devices

IontoPatch 80
LTS Therapy Systems, LLC · Device, Iontophoresis, Other Uses
1 recall0 reports
IontoPatch STAT
LTS Therapy Systems, LLC · Device, Iontophoresis, Other Uses
1 recall0 reports
ActivaPatch 001-40
Activatek Inc. · Device, Iontophoresis, Other Uses
1 report
CHATTANOOGA 5000022
Djo, LLC · Device, Iontophoresis, Other Uses
1 report

All Device, Iontophoresis, Other Uses devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page