Brasseler USA 5021285U0Recalls & reported problems
Peter Brasseler Holdings, LLC · FORZA F5 1:5 ATTACHMENT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887919660040), received between Feb 23, 2023 and Mar 10, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
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 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information3
Patient problems
- Burn(s)3
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
DURING A ROOT CANAL ON TOOTH #12, THE PATIENT SUFFERED A 3MM BURN TO UPPER LIP. THE PATIENT WAS GIVEN VITAMIN E OINTMENT AND WILL FOLLOW-UP IN 2 WEEKS.
Patient problems: Burn(s)
MAUDE report 16520582 ↗InjuryMar 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE DENTIST WAS PERFORMING A COMPOSITE FILLING ON TEETH #4 AND #31. THE PATIENT WAS BURNED ON THE INSIDE RIGHT CHEEK. THE BURN WAS THE SIZE OF A QUARTER. THERE WAS NO FOLLOW-UP TREATMENT.
Patient problems: Burn(s)
MAUDE report 16520439 ↗InjuryFeb 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
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
Patient problems: Burn(s); Partial thickness (Second Degree) Burn
MAUDE report 16432729 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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