APM Procedure Instrument with Matrix FG-003-00010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858395006295), received between Mar 21, 2020 and Mar 21, 2020 — 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR REPORTED THAT THE PATIENT HAD A HYPOCHLORITE EXTRUSION INTO THE FACIAL TISSUES. THE PATIENT HAD IMMEDIATE PAIN AND SWELLING FOLLOWED BY BRUISING. PATIENT SOUGHT FOLLOW UP EMERGENCY TREATMENT FOR PAIN. PATIENT SEEMED OKAY AT 6 WEEK FOLLOW UP.

  Patient problems: Swelling

  MAUDE report 9863292 ↗
• InjuryMar 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PROCEDURE WAS ON PATIENT'S UPPER MOLAR. ABOUT 90 SECONDS INTO THE NAOCI CYCLE, THE PATIENT RAISED HER HANDS AND SAID SHE WAS FEELING PAIN. THE DOCTOR DISCONTINUED THE GENTLEWAVE PROCEDURE, RINSED WITH DISTILLED WATER. SWELLING AND BRUISING WAS NOTED VERY QUICKLY. THE DOCTOR SENT THE PATIENT TO THE ENT IN THE BUILDING. THE PATIENT WAS GIVEN AN RX FOR STEROIDS AND PAIN MEDS. THE PATIENT HAD SWELLING AND BRUISING FOR A FEW WEEKS BUT IT EVENTUALLY RESOLVED AND SHE IS DOING FINE.

  Patient problems: Swelling

  MAUDE report 9863287 ↗
• InjuryMar 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER 4 MINUTES INTO THE NAOCI CYCLE, THE PATIENT JUMPED OUT OF THE CHAIR AND SAID HE COULD NOT BREATH. THERE WAS BLEEDING FROM THE TOOTH, BUT NOT EXCESSIVE. THE DOCTOR THOUGHT PATIENT INGESTED SOME NAOCI SO HE GAVE THE PATIENT WATER TO RINSE; AND AFTER FEW MINUTES THE PATIENT WAS ABLE TO CONTINUE WITH THE TREATMENT. THE TREATMENT WAS COMPLETED. THE PATIENT DID NOT HAVE SWELLING OR BRUISING AT THE TIME. HOWEVER, THE PATIENT WAS IN ER THAT NIGHT WHEN THE DOCTOR CALLED TO FOLLOW-UP. THE PATIENT STATED HE HAD EXCESSIVE AMOUNT OF NOSE BLEED AND HAD DIFFICULTY IN BREATHING. THE PATIENT WAS SENT HOME WITH AUGMENTIN 875MG EVERY 12 HOURS FOR 7 DAYS. AFTER 8 DAYS FOLLOWING THE INCIDENT, THE PATIENT CLAIMED HE WAS STILL CONGESTED, BUT NOSE BLEEDING HAD STOPPED. THE PATIENT HAS A FOLLOW-UP APPOINTMENT WITH HIS PHYSICIAN (GENERAL PRACTITIONER). THE DOCTOR ASKED THE PATIENT TO SCHEDULE AN APPOINTMENT FOLLOWING THE APPOINTMENT WITH HIS PHYSICIAN.

  Patient problems: Dyspnea; Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 9863280 ↗