Clinpro™ 12627Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30605861034556), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

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

Recent adverse event reports

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

• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DENTIST REPORTED THAT A PEDIATRIC PATIENT SWALLOWED A 3M¿ CLINPRO¿ SEALANT SYRINGE DISPENSING TIP DURING THE FOURTH PLACEMENT FROM A SINGLE SYRINGE ON (B)(6) 2020. THREE OTHER PLACEMENTS WERE COMPLETED DURING THE SAME DENTAL APPOINTMENT WITHOUT ISSUE. THE DENTIST INFORMED 3M THAT THE TIP HAD NOT BEEN RECHECKED DURING THE SEALING OF THE TEETH AND THE SEALANT WASN'T HARD TO EXPRESS. AN X-RAY WAS TAKEN AT AN EMERGENCY ROOM THE SAME DAY THE TIP WAS SWALLOWED. COLON PAIN WAS EXPERIENCED BY THE PATIENT THE NEXT DAY AND A CT SCAN WAS PERFORMED THAT SHOWED NO DAMAGE TO THE GASTROINTESTINAL TRACT. THE DISPENSING TIP WAS EXCRETED ON (B)(6) 2020. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Abdominal Pain; Pain

  MAUDE report 9655894 ↗