ActivaPatch 001-40Recalls & reported problems

Activatek Inc. · IntelliDose, 2.5 hour iontophoresis delivery · Class 2

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 00859975005219), received between Sep 6, 2016 and Sep 6, 2016 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Full thickness (Third Degree) Burn1

Recent adverse event reports

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

InjurySep 6, 2016Insufficient Device Problem Information; Insufficient Device Problem Information
PATCH WAS REMOVED FROM POUCH; PULL TAB WAS REMOVED ACTIVATING THE PATCH. PATIENT'S SKIN WAS INSPECTED AND FOUND TO BE INTACT. DURING INITIAL EXAMINATION OF THE AREA, SENSATION TO CRUDE LIGHT TOUCH WAS NOTED TO BE INTACT. TREATMENT AREA WAS WIPED CLEAN WITH THE PROVIDED ALCOHOL WIPE AND ALLOWED TO THOROUGHLY AIR DRY. UTILIZING A MARKED SYRINGE, 2.0 CC OF ACETIC ACID WAS DRAWN AND THEN USED TO HYDRATE THE ACTIVE IONIC SOLUTION RESERVOIR. NO DRY SPOTS ON THE PAD WERE OBSERVED. THE LINER WAS PEELED FROM THE PATCH; THE PATCH WAS PLACED DIRECTLY ON THE TREATMENT AREA. THE REMAINING RELEASE LINER OVER THE PULL TAB WAS REMOVED. THE FLASH SEQUENCE WAS OBSERVED, COMPARED TO THE FLASH SEQUENCE CHART PROVIDED AND FOUND TO BE ONE FLASH/30 SEC, INDICATING "LOW SKIN RESISTANCE, TREATMENT STARTED." PATIENT REPORTED SOME INITIAL STINGING AND BURNING SENSATIONS AND WAS INSTRUCTED TO REMOVE PATCH IF THOSE FEELINGS PERSISTED. BY THE TIME THE PATIENT LEFT THE CLINIC, 5 MINUTES LATER, SHE REPORTED THAT THE BURNING AND STINGING HAD DECREASED; SHE LEFT WITH THE PATCH IN PLACE; I EMPHASIZED AGAIN THAT IF ANY FURTHER BURNING CONTINUED, SHE WAS TO REMOVE THE PATCH IMMEDIATELY AND WASH THE AREA WITH WARM SOAP
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 5931376 ↗

Device details

UDI-DI	`00859975005219`
Brand	ActivaPatch
Model	001-40
Catalog no.	NC89188
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.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.