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

Model Number	12627
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Pain (1994)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem 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
• Common Device Name: SEALANT
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS-IRVINE; 2111 mcgaw avenue; irvine CA 92614
• MDR Report Key: 9655894
• Report Number: 3005174370-2020-00001
• Device Sequence Number: 2824306
• Product Code: EBC
• UDI-Device Identifier: 30605861034556
• UDI-Public: 30605861034556
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K992326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 12627
• Device Catalogue Number: 12627
• Device Lot Number: NA74760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR