MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-07 for TEMPHASE 28655 manufactured by Kerr Corporation.
[5626875]
A doctor alleged that a patient had experienced burns on their gingival after placement of the temphase material.
Patient Sequence No: 1, Text Type: D, B5
[13177999]
The patient had experienced burns on the gingival tissue on areas between teeth # 31 and #41, and on tooth #36. The dentist treated the area with a medicinal ointment. To date, the patient is doing fine. An evaluation is anticipated; but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[24359956]
An appearance test, gel time test and set time test were performed on the retain sample yielding results within specification. A dhr review revealed that there were no deviations from the manufacturing process. The product was accepted and released within specifications. In addition, no similar complaints were received with regard to this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2015-00008 |
| MDR Report Key | 4665761 |
| Report Source | 05 |
| Date Received | 2015-04-07 |
| Date of Report | 2015-03-12 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-12 |
| Device Manufacturer Date | 2014-10-18 |
| Date Added to Maude | 2015-04-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPHASE |
| Generic Name | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Product Code | EBG |
| Date Received | 2015-04-07 |
| Catalog Number | 28655 |
| Lot Number | 5322841 |
| Device Expiration Date | 2016-03-31 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-04-07 |