ERBE 20193-071Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04050147005136), received between Jul 27, 2022 and Jul 27, 2022 — 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 27, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2022, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE AT (B)(6). A MONITORING DISPERSIVE ELECTRODE ERBE NESSY PLATE 70 (MODEL XL23) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE]: "THE DISPERSIVE ELECTRODES SEEM TO BE STICKING TOO MUCH. REDDENING OF THE SKIN (RASH) WAS NOTICED AFTER REMOVING THE ELECTRODE." REQUESTING FURTHER INFORMATION WE HAVE BEEN INFORMED ON (B)(6) 2022 THAT [TRANSLATED FROM GERMAN LANGUAGE TO ENGLISH LANGUAGE] "IT WAS A REDDENING OF THE SKIN THAT DID NOT GO AWAY IMMEDIATELY. THE REDNESS HAD APPEARED UNDERNEATH THE ADHESIVE FOAM IN THE EDGE AREA. THIS IS AN ERBE NESSY PLATE 70 OF BATCH 211013-0804. THE DISPERSIVE ELECTRODE WITH BATCH NUMBER 210611-0804 RELATES ALSO TO ANOTHER INCIDENT OF THE SAME TYPE IN JAPAN (ESV-00-193668). WE HAVE ALREADY FILLED OUT A QUESTIONNAIRE ABOUT THIS INCIDENT." REVIEWING THIS QUESTIONAIRE IT IS FILLED IN PARTIALLY WITH INFORMATION. IN THE QUESTIONAIRE IT IS STATED THAT THE INCIDENT OCCURED ON (B)(6) 2022 IN (B)(6) HOSPITAL AND CONCERNS A CHILD. THE DISPERSIVE NEUTRAL ELECTRODE WAS ATTACHED TO THE CHILDS STOMACH "WHERE EXACTL

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 15109547 ↗