MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-04 for 3M ESPE RELYX UNICEM 2 AUTOMIX 56846 manufactured by 3m Deutschland Gmbh.
[44448199]
Since this event involved three medical devices, three mdrs are being submitted. This mdr report is for the third medical device. Mdrs 300517430-2016-00048 and 3005174370-2016-00049 are for the first and second medical device, respectively. Device was not sent to us.
Patient Sequence No: 1, Text Type: N, H10
[44448200]
On (b)(6) 2016, a dental professional reported that patients with a 3m espe lava ultimate cad/cam restorative for cerec crowns (2914a2-lt and 2914a3-lt) secured with relyx unicem 2 automix required tooth extraction. Additional information regarding the number of patients impacted and details on the cases have been requested; to date, no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00005 |
| MDR Report Key | 5633050 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-04 |
| Date of Report | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-04 |
| 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 | 2016-05-04 |
| Catalog Number | 56846 |
| 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 | 2016-05-04 |