Brasseler USA 5030964U0Recalls & reported problems
Peter Brasseler Holdings, LLC · MP3S MULTI FL 10MM SAMPLE 3P · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00887919966791), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 injury.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Use of Device Problem; Use of Device Problem
WHILE REMOVING ORTHO BUTTONS, A DARK PURPLE MP3 POLISHER CUT THE PATIENT'S LIP AND CHEEK. THE PATIENT WAS SENT TO AN ORAL SURGEON FOR STITCHES. THE DOCTOR WAS USING THE POLISHER WITH AN AIR DRIVEN SLOW SPEED (CONTROLLED BY FOOT PEDAL), FASTER THAN 7K SPEED.
Patient problems: Laceration(s)
MAUDE report 19608172 ↗
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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