MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-31 for SURESMILE ALIGNER PATIENT KIT ORX00004 manufactured by Dentsply Sirona Orthodontics Inc..
[125686803]
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. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[125686804]
It was reported that a patient experienced an allergic reaction after using the suresmile aligner patient kit. The reported symptoms include swollen lips, swollen gingiva, numb tongue and difficulty breathing. The patient went to the emergency room for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036212-2018-00006 |
| MDR Report Key | 8024742 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-31 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-10-31 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | DENTSPLY SIRONA ORTHODONTICS 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 | SURESMILE ALIGNER PATIENT KIT |
| Generic Name | DENTAL PROPHYLAXIS KIT |
| Product Code | NYC |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-11-06 |
| Model Number | NA |
| Catalog Number | ORX00004 |
| Lot Number | SO-000002641403 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY SIRONA ORTHODONTICS INC. |
| Manufacturer Address | 7290 26TH COURT EAST SARASOTA FL 34243 US 34243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-10-31 |