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 2016-04-13 for 3M ESPE RELYX UNICEM 2 AUTOMIX 56858 manufactured by 3m Deutschland Gmbh.
[42606333]
Exact data on the symptoms which led to the necessity of the root canal treatments were not given by the dentist. As described above it was found out that a handling error led to the adverse events. 3m espe relyx unicem 2 automix has been assessed for biocompatibility and has been found to be safe for its intended use. Device was not sent to us.
Patient Sequence No: 1, Text Type: N, H10
[42606334]
On (b)(6) 2016, a dentist reported that several patient required root canal treatment after the use of 3m espe relyx unicem 2 automix. These patients had crowns made from the competitor material e. Max cad from ivoclar vivadent. In an interview with the dentist it showed that there's underlying an application error. The dentist overdried during the application which led to pain symptoms and subsequent to the root chanel treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00004 |
| MDR Report Key | 5575067 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-04-13 |
| Date of Report | 2016-03-15 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-04-13 |
| 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-STRABE 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 UNICEM 2 AUTOMIX |
| Generic Name | CEMENT, DENTAL |
| Product Code | EMA |
| Date Received | 2016-04-13 |
| Catalog Number | 56858 |
| 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-STRABE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-13 |