MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-15 for IMPRESSIX ALGINATE XTRA FASTSET IE001-20 manufactured by Raintree Essix Inc..
[77705453]
While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material. Therefore, this event meets the criteria for reportability per 21 cfr part 803. We have evaluated the batch reports and retain samples. We cannot find anything unusual. We have to assume that the patient is sensitive for one or more of the ingredients.
Patient Sequence No: 1, Text Type: N, H10
[77705454]
It was reported that a patient experienced an allergic reaction to impressix alginate impression material. The patient was sent to the er for treatment. Additional details have been requested, but are not yet available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036212-2017-00003 |
| MDR Report Key | 6645287 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-05-10 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-06-15 |
| 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 | EMERGENCY MEDICAL TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457551 |
| Manufacturer G1 | RAINTREE ESSIX INC. |
| Manufacturer Street | 7290 26TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPRESSIX ALGINATE XTRA FASTSET |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2017-06-15 |
| Model Number | NA |
| Catalog Number | IE001-20 |
| Lot Number | 151001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAINTREE ESSIX INC. |
| Manufacturer Address | 7290 26TH COURT EAST SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-06-15 |