MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-18 for 3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT 76976 manufactured by 3m Deutschland Gmbh.
[80379718]
This event involved two 3m products; therefore, two manufacturer reports are being submitted. This report represents the second product. Manufacturer report 3005174370-2017-00042 represents the first product.
Patient Sequence No: 1, Text Type: N, H10
[80379719]
On (b)(6) 2017, 3m was notified that a (b)(6) female patient required root canal treatment on tooth #28 following a dental treatment with 3m espe filtek bulk fill posterior restorative and 3m espe elipar deep cure-s led curing lite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00009 |
| MDR Report Key | 6723564 |
| Date Received | 2017-07-18 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-07-07 |
| Date Added to Maude | 2017-07-18 |
| 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-STRASSE 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 | 0 |
| Brand Name | 3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2017-07-18 |
| Model Number | 76976 |
| Catalog Number | 76976 |
| 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-STRASSE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-07-18 |