MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-19 for DT ILLUSION XRO SL POST V041941000002 manufactured by Recherches Techniques Dentaires (r.t.d.).
[139290832]
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. This submission is being made after an acquisition and internal audit of rtd.
Patient Sequence No: 1, Text Type: N, H10
[139290833]
It was reported that a patient experienced an allergic reaction to dt illusion xro sl endodontic post. The clinician stated that the patient's reaction occurred on the same day as treatment and that the reaction was visible on the patient's hands and body. The patient is now undergoing unknown treatment with an allergist. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001226627-2016-00003 |
| MDR Report Key | 8434543 |
| Date Received | 2019-03-19 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2019-03-19 |
| 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 | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Street | 3 RUE LOUIS NEEL |
| Manufacturer City | ST. EGREVE ISERE, 38120 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DT ILLUSION XRO SL POST |
| Generic Name | POST, ROOT CANAL |
| Product Code | ELR |
| Date Received | 2019-03-19 |
| Model Number | NA |
| Catalog Number | V041941000002 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) |
| Manufacturer Address | 3 RUE LOUIS NEEL ST. EGREVE ISERE, 38120 FR 38120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-19 |