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 2016-12-21 for 3M ESPE RELYX ULTIMATE manufactured by 3m Deutschland Gmbh.
[63056772]
This event involved two medical devices, therefore two manufacturer reports are being submitted. This report describes the second device. Manufacturer report number 9611385-2016-00014 describes the first device.
Patient Sequence No: 1, Text Type: N, H10
[63056773]
On november 25, 2016 it was reported to 3m (b)(4) that after a dental treatment on (b)(6) 2016 with our products 3m espe scotchbond universal and 3m espe relyx ultimate a patient started to suffer from pulpitic pain. Subsequently a root channel treatment was performed on (b)(6) 2016. Currently the patient is doing fine. A follow-up interview with the dentist showed, that the crown was attached before with a harvard cement from a competitor, but had to be removed because of decementation. The crown was then attached with 3m espe scotchbond universal and 3m espe relyx ultimate. The reason for the adverse event is highly probably a pulpitic infection caused by leakage after the debonding of the crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00015 |
| MDR Report Key | 6196864 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-12-21 |
| Date of Report | 2016-11-25 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2016-11-25 |
| Date Added to Maude | 2016-12-21 |
| 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 | DR. THOMAS MEINDL |
| Manufacturer Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS, 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH-SEEFELD |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD, 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE RELYX ULTIMATE |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-12-21 |
| Lot Number | 631761 |
| Device Expiration Date | 2017-11-01 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRASSE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-21 |