MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-10 for RELYX UNICEM 2 CEMENT 56848 manufactured by 3m Deutschland Gmbh.
[33272394]
Since this event involved four medical devices, four manufacturer reports are being submitted. This report describes the second device. Manufacturer report numbers 3005174370-2015-00126, 9611385-2015-00108, and 9611385-2015-00109, describe the first, third and fourth device, respectively.
Patient Sequence No: 1, Text Type: N, H10
[33272395]
On (b)(6) 2015, a dental assistant reported one patient who required a tooth extraction. The patient had a restoration made from 3m espe lava ultimate cad/cam restorative for cerec which was secured with 3m espe relyx ultimate adhesive resin cement, relyx univcem 2 cement and scotchbond universal adhesive. On (b)(6) 2015, it was reported that the doctor was not 100% sure that the extraction was due to the crown because there were other factors involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2015-00107 |
| MDR Report Key | 5287967 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-12 |
| Date Mfgr Received | 2015-11-12 |
| Date Added to Maude | 2015-12-10 |
| 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 | DENTAL ASSISTANT |
| 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, D82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX UNICEM 2 CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2015-12-10 |
| Catalog Number | 56848 |
| 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 | 2015-12-10 |