MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-11-02 for PRIME & BOND NT 606.67.240 manufactured by Dentsply Detrey Gmbh.
[126065955]
Follow-up with the doctor determined that an error in their technique may have caused the chemical burns. During application of the prime & bond nt on a brush (instead of the applicator tip), a possible contamination of the gloves was described by the doctor. Furthermore, it was observed that the burns always occurred on the side of the treating dentist that typically would stabilize instruments by touching the site of burn with their gloved fingers. The dfu clearly warns users to avoid skin contact and gives instructions for what to do if skin contact is made. Since a serious injury resulted, this event is reportable per 21 cfr part 803. This report if for the second patient. The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[126065956]
In this event a doctor reported that he had four pediatric patients that were all treated with prime & bond nt and all four patient's had a chemical burn on the outside right corner of their mouths after treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00009 |
| MDR Report Key | 8035618 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-02 |
| Date Mfgr Received | 2018-10-04 |
| Date Added to Maude | 2018-11-02 |
| 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 DETREY GMBH |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ, 78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIME & BOND NT |
| Generic Name | AGENT, TOOTH BONDING, RESIN |
| Product Code | KLE |
| Date Received | 2018-11-02 |
| Returned To Mfg | 2018-10-15 |
| Model Number | NA |
| Catalog Number | 606.67.240 |
| Lot Number | 1801000924 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY GMBH |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ, 78467 GM 78467 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-02 |