MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-07 for ACCUDENT XD TRAY MATERIAL 673471 manufactured by Ivoclar Vivadent, Inc..
[101703701]
Accudent xd instruction for use contains the word "spearmint" under composition of tray material and under composition of syringe material. Due to the presence of spearmint in accudent xd, the dental office should not have used the product on a patient with a mint allergy. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[101703702]
Patient reported a mint allergy in her medical history. The doctor's staff checked packaging and labeling of accudent xd and could not find any evidence of the word "mint". As a result, the dental staff assumed the product was safe to use for this patient. A few hours after exposure, the patient had significant respiratory symptoms, and developed painful ulcers on her lips and buccal mucosa. The patient managed her reaction with benadryl. Accudent xd ifu does contain the word "spearmint" under composition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316092-2018-00002 |
| MDR Report Key | 7319882 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-07 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-02-20 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-07 |
| 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 | MRS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DRIVE |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUDENT XD TRAY MATERIAL |
| Generic Name | MATERIAL, IMPRESSION |
| Product Code | ELW |
| Date Received | 2018-03-07 |
| Catalog Number | 673471 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, INC. |
| Manufacturer Address | 175 PINEVIEW DRIVE AMHERST NY 14228 US 14228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-07 |