SIGNAGEL ELECTRODE GELRecalls & reported problems
Parker Laboratories Inc · Signagel Electrode Gel, 250 gram tube · 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 10855683006217), received between Nov 19, 2019 and Nov 19, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nausea1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 PATI
Patient problems: Nausea; Swelling
MAUDE report 9342304 ↗
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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.
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