MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-03-14 for RELYX LUTING LUTING CEMENT 3505 manufactured by 3m Espe Dental Products.
[69945812]
It is not known what role, if any, the 3m cement may have played in this reported outcome. Other factors, such as prior tooth history, patient factors or dental treatment, may have played a role in the need for root canal therapy. Relyx luting cement has a highly favorable clinical usage history and has been shown to be safe for its intended use.
Patient Sequence No: 1, Text Type: N, H10
[69945813]
On (b)(6) 2017, a dentist reported that a male patient required a root canal (affected tooth number not provided). On (b)(6) 2010, 3m espe relyx luting luting cement was used to place a crown. Approximately one year later, the patient saw an endodontist who suggested that the patient had pulpitis that was likely due to a potential allergy to the cement. The root canal was performed on (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005174370-2017-00026 |
| MDR Report Key | 6404691 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-14 |
| Date of Report | 2017-03-02 |
| Date of Event | 2011-09-12 |
| Date Mfgr Received | 2017-03-02 |
| Date Added to Maude | 2017-03-14 |
| 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-IRVINE |
| Manufacturer Street | 2111 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX LUTING LUTING CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2017-03-14 |
| Catalog Number | 3505 |
| 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 | 2017-03-14 |