MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for SURESMILE ALIGNER 856379007023 manufactured by Orametrix Inc..
[134735301]
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. Please note, this event was originally submitted as mfr report # 1036212-2018-00006 under dentsply sirona orthodontics. In the original submission, this event was reported under the kit that is manufactured by dentsply sirona orthodontics by mistake and should have been reported under orametrix inc. Since they are the manufacturer of the device that caused/contributed to this event. Orametrix was recently acquired by dentsply sirona inc. , who is also the parent company of dentsply sirona orthodontics.
Patient Sequence No: 1, Text Type: N, H10
[134735302]
It was reported that a patient experienced an allergic reaction after using the suresmile aligner. 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 | 1649995-2018-00001 |
| MDR Report Key | 8292933 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-30 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2019-01-31 |
| 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 | ORAMETRIX INC. |
| Manufacturer Street | 2350 CAMPBELL CREEK BLVD. SUITE 400 |
| Manufacturer City | RICHARDSON TX 75082 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75082 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURESMILE ALIGNER |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2019-01-31 |
| Model Number | NA |
| Catalog Number | 856379007023 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORAMETRIX INC. |
| Manufacturer Address | 2350 CAMPBELL CREEK BLVD. SUITE 400 RICHARDSON TX 75082 US 75082 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-31 |