MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-16 for RELYX ULTIMATE ADHESIVE RESIN CEMENT 56888 manufactured by 3m Deutschland Gmbh.
[52181600]
This event involved two medical devices, therefore two manufacturer reports are being submitted. This report describes the first device. Manufacturer report number 9611385-2016-00009 describes the second device.
Patient Sequence No: 1, Text Type: N, H10
[52181601]
On (b)(6) 2016, a dental professional informed 3m about a patient who required root canal. On (b)(6) 2015, the patient had a porcelain crown (non-3m brand) secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive. The root canal was performed on (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00008 |
| MDR Report Key | 5878375 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-16 |
| Date of Report | 2016-05-11 |
| Date of Event | 2015-10-14 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-08-16 |
| 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, 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 ULTIMATE ADHESIVE RESIN CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-08-16 |
| Catalog Number | 56888 |
| 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 | 2016-08-16 |