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Skintact DF27NCRecalls & reported problems

Leonhard Lang GmbH · Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 19005531506067), received between Oct 23, 2025 and Oct 23, 2025 — classified as 1 malfunction.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • No Apparent Adverse Event1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 23, 2025No Apparent Adverse Event; No Apparent Adverse Event

    ON (B)(6) 2025, WE HAVE BEEN INFORMED ABOUT A MALFUNCTION WITH A DEFIBRILLATION ELECTRODE SET AT AN UNKNOWN USER SITE IN THE UK. SKINTACT DEFIBRILLATION ELECTRODES MODEL DF27NC AND A PHILIPS FR2+ DEFIBRILLATOR HAD BEEN USED. THE INITIAL WAS STATING THAT "I AM ENCOUNTERING SOME ISSUES WITH THE DEFIBRILATOR PADS FOR PHILIPS FR. THE DEFIBRILLATOR DOES NOT RECOGNISE THEM (THE PADS) WHEN PLUGGED IN." WE HAVE REQUESTED FURTHER INFORMATION AND HAVE RECEIVED LATER ON PICTURES AND A VIDEO SHOWING THE CLAIMED FAILURE. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

    MAUDE report 23364577 ↗

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