MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-09 for 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL 4911A2B manufactured by 3m Espe Dental Products.
[82400041]
A follow-up interview by 3m showed a high probability that disregard of the instructions for use may have led to these adverse events. It appears that there's is a certain possibility for leakages and air inclusions, which subsequently may have resulted in the pulpitic sensitivities.
Patient Sequence No: 1, Text Type: N, H10
[82400042]
On (b)(6) 2017, it was reported to 3m that a (b)(6) year-old male patient required a root canal following unresolved sensitivity after a restorative treatment with 3m espe filtek supreme xte universal restorative (also known as filtek supreme ultra universal restorative). On (b)(6) 2017, the restorative was removed and replaced with a cement containing eugenol; the symptoms persisted and a root canal treatment was performed on (b)(6) 2017. The root canal treatment was performed without any complications and the patient fully recovered. Upon follow-up, the dentist revealed that there were two other root canal treatments involving 3m espe filtek supreme xte universal restorative in the past, but did not add any further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00043 |
| MDR Report Key | 6778549 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-09 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-10 |
| Date Added to Maude | 2017-08-09 |
| 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 | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551441000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE FILTEK SUPREME ULTRA UNIVERSAL |
| Generic Name | MATERIAL, TOOTH SHADE, RESIN |
| Product Code | EBF |
| Date Received | 2017-08-09 |
| Catalog Number | 4911A2B |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 2510 CONWAY AVENUE ST. PAUL MN 551441000 US 551441000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-09 |