MAUDE Adverse Event Report: PARKER LABORATORIES, INC SIGNAGEL; ELECTRODE GEL

Model Number 15-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Swelling (2091)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

A technical data sheet was provided to the researcher at the time the event was reported.The tds includes a reference to the preservative parabens.The instructions for use include a warning that signagel should not be used on patients with a known sensitivity to parabens; however, it is noted that the patient did not report a sensitivity to parabens.Nausea and swelling are not typically associated with allergic reactions that may occur as a result of use of the gel.Typically, a patient with an allergic response would experience itching and redness at the application site.As a result, parker forwarded a description of the event to biosemi, the manufacturer of the electrode system, who advised that they have not received any related reports for their system.Because the lot number is not known, the manufacturing records and retained samples for the lot cannot be reviewed.We have not received any related reports of head swelling or nausea resulting from use of this gel.Therefore we cannot confirm that the gel contributed to the event.

Event Description

On october 4, 2019, parker laboratories was contacted by a postdoctoral researcher conducting a study who reported that after using signagel electrode gel on a participant during eeg measurements, the participant experienced an allergic reaction on the head (swollen head and nausea).The researcher advised this was the first time he or any of the other researchers had received a report of this nature involving the gel.Parker followed up for additional details of the event.The gel appeared to have normal color, odor, and appearance at the time of application.The researcher advised that he does not have the lot number of the product involved in the event, as it had already been discarded by the cleaning staff.The participant is a (b)(6) female; the weight is unknown.Previously known allergies for the patient include chemicals in hair paints.This was the first time the patient had been exposed to signagel.On october 8, 2019, the researcher provided an update that the participant had elected to go to a hospital for medication and their condition had resolved.He also advised that the study was conducted using a biosemi electrode system.Parker followed up for details of the patient's diagnosis and treatment.On october 14, 2019, the researcher advised that the participant had received anti-allergic tablets (tavegil) and an anti allergic injection.Despite several follow up attempts, the researcher has been unable to provide additional information related to the injection.He did advise that the participant did not experience any redness or itching at the application site while they were in the lab.

• Brand Name: SIGNAGEL
• Type of Device: ELECTRODE GEL
• Manufacturer (Section D): PARKER LABORATORIES, INC; 286 eldridge road; fairfield NJ 07004 7261
• Manufacturer (Section G): PARKER LABORATORIES, INC; 286 eldridge road; fairfield NJ 07004 7261
• Manufacturer Contact: candy beck ; 286 eldridge road; fairfield, NJ 07004-7261 ; 9732769500
• MDR Report Key: 9342304
• MDR Text Key: 184534655
• Report Number: 2212018-2019-00001
• Device Sequence Number: 1
• Product Code: GYB
• UDI-Device Identifier: 20855683006214
• UDI-Public: 20855683006214
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 15-25
• Device Catalogue Number: 15-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR