MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for EXA'LENCE REGULAR HEAVY 48 ML 137004 manufactured by Gc America Inc..
[101119076]
The patient did have a known allergy to mint. The dentist had an impression material that they knew had a mint in it and couldn't use and decided to use exa'lence instead. The dentist was unaware that exa'lence had any mint flavor in it because they could not find any information on the box. After the patient left the office, she contacted the dentist office via email informed that she was experiencing respiratory like symptoms and contacted her physician. The dentist ofiice stated that the patient took benadryl and it alleviated the problem and she is fine at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2018-00001 |
| MDR Report Key | 7301236 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-01-30 |
| Date Facility Aware | 2018-02-01 |
| Report Date | 2018-03-05 |
| Date Reported to FDA | 2018-03-05 |
| Date Reported to Mfgr | 2018-02-01 |
| Date Mfgr Received | 2018-02-01 |
| Device Manufacturer Date | 2016-09-29 |
| Date Added to Maude | 2018-02-27 |
| 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. MARK HEISS,DDS |
| Manufacturer Street | 3737 W.127TH STREET |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer Phone | 7089263090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXA'LENCE REGULAR HEAVY 48 ML |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2018-02-27 |
| Catalog Number | 137004 |
| Lot Number | 1609291 |
| Device Expiration Date | 2019-03-29 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC AMERICA INC. |
| Manufacturer Address | 3737 W. 127TH STREET ALSIP IL 60803 US 60803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-02-27 |