MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS-IRVINE 3M CLINPRO SEALANT

Model Number 12627

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 01/06/2020

Event Type  Injury  

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.

Event Description

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.

• Brand Name: 3M CLINPRO SEALANT
• Type of Device: SEALANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• Manufacturer Contact: suzanne leung ; 2510 conway avenue; building 275-02-w-08; st. paul, MN 55144-1000 ; 6515758052
• MDR Report Key: 9655894
• MDR Text Key: 177373747
• Report Number: 3005174370-2020-00001
• Device Sequence Number: 1
• Product Code: EBC
• UDI-Device Identifier: 30605861034556
• UDI-Public: 30605861034556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12627
• Device Catalogue Number: 12627
• Device Lot Number: NA74760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR