Skintact FS-RG1 /10Recalls & reported problems
Leonhard Lang GmbH · ECG Electrodes · Class 2
All models of Skintact (14)
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 19005531505756), received between Feb 28, 2023 and Feb 28, 2023 — 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
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ON JANUARY 31ST, 2023, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES IN ALLERGOLOGY IN A PUBLIC HOSPITAL OSPEDALE SAN GIOVANNI DI DIO, IN FLORENCE, ITALY. SKINTACT ELECTRODES MODEL FS-RG1/10 WERE USED. THE INITIAL REPORTER WAS REQUIRING "ONE PATIENT SHOWED SUSPICIOUS ALLERGIC DERMATITIS AFTER USING YOUR ELECTROCARDIOGRAM ELECTRODES FS-RG1/10. THEREFORE I ASK YOU ABOUT THE CHEMICALS THAT CONSTITUTE EACH PART OF THE ELECTRODES (E.G. THE FOAM, THE GLUE...)." NO FURTHER DETAILS HAVE BEEN DISCLOSED DESPITE REPEATED REQUESTS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 16451138 ↗
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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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