MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-07-08 for ELIPAR HIGHLIGHT 076700 manufactured by Espe Dental-medizin Gmbh & Co.kg..
[119853]
On june 10th, a dentist called and reported of burning-blistering at the gingiva around a tooth after application of elipar highlight for light curing of a composite restorative material, which the dentist believed may have been due to the development of heat during the application of the light source. The pt was treated by cooling the gingive, followed by irrigating with chlorhexamed. After one week the pt's gingive has been completely recovered. Although the event occurred on march 4, 1998, espe was not notified until june 10. Due to the pt's deep cavity, the dentist performed a subgingival dissection using retraction fibers. Two pins were inserted into the root canal and coated with - probably 2 layers of - vivadent's tetric composite restorative material. Light curing was undertaken two times (40 seconds each time). The "one-step modus" was used at the highest light intensity. The tooth subsequently was crowned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-1998-00004 |
| MDR Report Key | 176158 |
| Report Source | 05 |
| Date Received | 1998-07-08 |
| Date of Report | 1998-06-17 |
| Date of Event | 1998-03-04 |
| Date Mfgr Received | 1998-06-10 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 1998-07-10 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELIPAR HIGHLIGHT |
| Generic Name | LIGHT CURING UNIT |
| Product Code | EAY |
| Date Received | 1998-07-08 |
| Returned To Mfg | 1998-06-10 |
| Model Number | NA |
| Catalog Number | 076700 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171274 |
| Manufacturer | ESPE DENTAL-MEDIZIN GMBH & CO.KG. |
| Manufacturer Address | ESPE PLATZ SEEFELD GM D-82229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-08 |