MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-21 for RELYX ULTIMATE ADHESIVE RESIN CEMENT 56890 manufactured by 3m Deutschland Gmbh.
[34071604]
Patient-specific information was not obtained despite multiple attempts at follow-up. As such, this report is being made to cover all three possibly impacted patients. Since this event involved three medical devices, three manufacturer reports are being submitted. This report describes the second device. Manufacturer report numbers 3005174370-2015-00130 and 9611385-2015-00111 describe the first and third device, respectively.
Patient Sequence No: 1, Text Type: N, H10
[34071625]
On (b)(6) 2015, a dental professional informed 3m about three patients who required endodontic treatment. These patients had a 3m espe lava ultimate crowns secured with 3m espe relyx ultimate adhesive resin cement and 3m espe scotchbond universal adhesive. No details on dates of treatment, pre-existing tooth health or outcomes were made available to 3m despite multiple attempts at follow-up. As such, the role that the 3m products may or may not have played in the reported endodontic events is unclear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2015-00110 |
| MDR Report Key | 5316995 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-21 |
| Date of Report | 2015-11-24 |
| Date Mfgr Received | 2015-11-24 |
| Date Added to Maude | 2015-12-21 |
| 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-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 | 2015-12-21 |
| Catalog Number | 56890 |
| 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 | 2015-12-21 |