Skip to content

Hygenic H00750Recalls & reported problems

Coltene/Whaledent Inc · FlexiDam 3.91x4.12 Purple · Class 1

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 D661H007501), received between Aug 23, 2018 and Aug 23, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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

  • Loose or Intermittent Connection1
  • Loss of or Failure to Bond1
  • Material Integrity Problem1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 23, 2018Loss of or Failure to Bond; Loose or Intermittent Connection; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem

    DENTAL DAM IS COMING LOOSE FROM FRAME.

    Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

    MAUDE report 7808766 ↗

Other Dam, Rubber devices

All Dam, Rubber devices →

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