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Hygenic H09945Recalls & reported problems

Coltene/Whaledent Inc · FlexiDam 6x6 Purple · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D661H099451), received between Dec 26, 2019 and Dec 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Itching Sensation1
  • Urticaria1

Recent adverse event reports

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

  • InjuryDec 26, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

    DURING A DENTAL PROCEDURE THE PRODUCT LISTED AND OTHERS WERE USED ON AN ADULT MALE. AN HOUR INTO THE PROCEDURE THE ADULT MALE DEVELOPED ITCHING AND HIVES. IMMEDIATELY THE DENTIST STOPPED THE PROCEDURE AND ADMINISTERED A BENADRYL SHOT. AT THIS TIME THE ADULT MALE IS HOME AND IN CONTACT WITH THE DENTIST TO FIGURE OUT WHAT PRODUCT WAS USED DURING THE PROCEDURE.

    Patient problems: Itching Sensation; Urticaria

    MAUDE report 9521323 ↗

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.