ESTEEM+ 421622Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00768455143351), received between Jun 19, 2023 and Jun 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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

Recent adverse event reports

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

• MalfunctionJun 19, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE END USER REPORTED THAT THE TAB ON INTERLOCKING CLOSURE SCRATCHED HER LEG AS SOON AS IT WAS APPLIED, AND IT WAS ALSO DESCRIBED THAT DUE TO THE ISSUE, END USER TUCKED TAIL INTO THE COMFORT PANEL. ADDITIONALLY, END USER STATED THAT SINCE THE INTERLOCKING CLOSURE WAS NOT SEALED DUE TO WHICH SHE FELT THAT PIECE WAS NOT SECURED, AND IT WAS FEELING ROUGH TO HER AND RUBBING ONTO HER SKIN. ALTHOUGH THERE WAS NO HARM OF SKIN REDNESS OR BROKEN SKIN EXPERIENCED, HOWEVER, THE ISSUE WAS EMBARRASSING AND FRUSTRATING. SHE USED THE BINDER CLIP TO KEEP THE TAIL CLOSURE CLOSED, HOWEVER, THERE WAS NO REPORT OF PAPER CLIP SCRATCHING HER. A PHOTOGRAPH WAS PROVIDED BY THE NURSE TO ILLUSTRATE THE ISSUE EXPERIENCED BY THE END USER.

  Patient problems: Discomfort; Distress

  MAUDE report 17150119 ↗