MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-10 for FUJI PLUS CONDITIONER UNK 433125 manufactured by Gc America, Inc..
[18328112]
Dr was cementing a crown with fuji plus cement. After placing the fuji plus conditioner on tooth, the pt placed tongue on the tooth and experienced a bitter taste. She returned to dental office later complaining of redness and burning on tongue, gum tissue and throat. Burning sensation continued into the evening hours. Pt went to er room and was treated for a chemical burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-1998-00002 |
| MDR Report Key | 176214 |
| Date Received | 1998-07-10 |
| Date of Report | 1998-06-10 |
| Date of Event | 1998-06-03 |
| Date Facility Aware | 1998-06-10 |
| Report Date | 1998-07-10 |
| Device Manufacturer Date | 1971-11-01 |
| Date Added to Maude | 1998-07-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJI PLUS CONDITIONER |
| Generic Name | TOOTH SURFACE CONDITIONER |
| Product Code | EBC |
| Date Received | 1998-07-10 |
| Model Number | UNK |
| Catalog Number | 433125 |
| Lot Number | 261171 |
| ID Number | * |
| Device Expiration Date | 1999-11-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 171329 |
| Manufacturer | GC AMERICA, INC. |
| Manufacturer Address | 3737 WEST 127TH ST. ALSIP IL 60803 US |
| Baseline Brand Name | FUJI PLUS CONDITIONER |
| Baseline Generic Name | TOOTH CONDITIONER |
| Baseline Model No | NA |
| Baseline Catalog No | 433125 |
| Baseline ID | NA |
| Baseline Device Family | FUJI PLUS CEMENT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K946100 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-07-10 |