Skintact T-60Recalls & reported problems
Leonhard Lang GmbH · ECG Electrodes · Class 2
Data updated Oct 13, 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 19005531580463), received between Aug 10, 2017 and Aug 10, 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Skin Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2017, WE HAVE BEEN INFORMED BY (B)(6), ABOUT AN INCIDENT INVOLVING AN UNKNOWN ECG HOLTER MONITOR AND SKINTACT T-60 ECG ELECTRODES. A HOLTER PROCEDURE OF 48 HOURS WAS PERFORMED. THE PATIENT'S BODY TYPE WAS DESCRIBED AS SLIM AND THE SKIN TYPE AS "NORMAL". IN HER MEDICAL HISTORY COPD AND A LATEX ALLERGY WERE LISTED. THE SKIN WAS CLEANED WITH SKIN PREP (MODEL SMITH & NEPHEW SKIN PREP) AND DRIED. FIVE ELECTRODES WERE APPLIED IN THE CHEST AREA. THE SKIN HAS NOT BEEN DISINFECTED AND NOT BEEN SHAVEN. THE ELECTRODES ADHERED PROPERLY. WHEN THE PATIENT REMOVED THE ELECTRODES AFTER THE PROCEDURE, ABRASIONS AND REDNESS WERE DETECTED UNDERNEATH THE GEL AND THE ADHESIVE AREA OF AT LEAST 4 OF THE APPLIED ELECTRODES. THE SIZE OF THE INJURIES WAS CHARACTERIZED AS "QUARTER SIZE SPOTS". IT WAS REPORTED THAT NO TREATMENT WAS NECESSARY FOR THE INJURIES, "JUST MONITORING SITE FOR INCREASED REDNESS + SIGNS OF INFECTION".
Patient problems: Skin Irritation
MAUDE report 6784131 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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