MEDICOM SAFEBASICS 700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10686864049231), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON (B)(6) 2019 FOR MEDICOM SAFEBASICS SALIVA EJECTOR. ITEM CODE 700 LOT# 20181426. THE SALIVA EJECTOR IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE DYN. SALIVA EJECTORS ARE USED IN DENTRISTRY IN ORDER TO REMOVE SALIVA, BLOOD OR OTHER DEBRIS FROM THE MOUTH DURING DENTAL PROCEDURES. THIS DISPOSABLE DEVICE IS CONNECTED TO AN ACTIVE DEVICE, NORMALLY A PNEUMATIC SYSTEM SUCTION CIRCUIT. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED " THE BLUE TIPS ARE POPPING OFF IN PEOPLE'S MOUTHS AND THE TIPS ARE EVEN OFF THE SALIVA EJECTORS IN THE BAGS." THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10687288 ↗