inforMED
InjuryEBC

3M CLINPRO SEALANT

Received Jan 31, 2020 · Event occurred Jan 6, 2020

Report 3005174370-2020-00001 · MDR key 9655894

Device

Generic name

Sealant

Model number

12627

Catalog number

12627

Lot number

NA74760

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

6 YR

  • Abdominal Pain
  • Pain
  • Abdominal Pain
  • Pain

Narrative

Additional Manufacturer Narrative

PATIENT IDENTIFIER, SEX, WEIGHT, ETHNICITY, RACE: NO INFORMATION WAS PROVIDED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT THE SAMPLE. 3M WILL CONTINUE TO MONITOR. THE PRODUCT IFU FOR 3M¿ CLINPRO¿ SEALANT DOES CONTAIN INSTRUCTIONS ON HOW TO PREPARE THE PRODUCT FOR USE, INCLUDING TO TWIST A DISPOSABLE DISPENSING TIP SECURELY ONTO THE SYRINGE, TO EXPRESS A SMALL AMOUNT OF MATERIAL ONTO A MIXPAD TO ASSURE THE DELIVERY SYSTEM IS NOT CLOGGED.

Description of Event or 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.