MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-31 for 3M? CLINPRO? SEALANT 12627 manufactured by 3m Espe Dental Products-irvine.
[177373747]
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.
Patient Sequence No: 1, Text Type: N, H10
[177373748]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2020-00001 |
| MDR Report Key | 9655894 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUZANNE LEUNG |
| Manufacturer Street | 2510 CONWAY AVENUE BUILDING 275-02-W-08 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6515758052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? CLINPRO? SEALANT |
| Generic Name | SEALANT |
| Product Code | EBC |
| Date Received | 2020-01-31 |
| Model Number | 12627 |
| Catalog Number | 12627 |
| Lot Number | NA74760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS-IRVINE |
| Manufacturer Address | 2111 MCGAW AVENUE IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-31 |