HEMADERM ENT0001-2Recalls & reported problems
Davol Inc. · ENT Kit with HEMADERM, (Contents: 1) 2g bellows container and (Contents: 2) ENT Applicators · Class 2 · Implant
- 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 00801741044083), received between Dec 18, 2024 and Dec 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- 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.
MalfunctionDec 18, 2024Use of Device Problem; Use of Device Problem
AS REPORTED, DURING A PROCEDURE AN ARISTA HEMADERM KIT WHICH HAD A LABELED EXPIRATION DATE ON (B)(6) 2024 WAS USED IN THE PATIENT ON (B)(6) 2024. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20966123 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.