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 2018-11-29 for PRIME&BOND ACTIVE 606.67.343 manufactured by Dentsply Detrey Gmbh.
[128857414]
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 evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[128857415]
It was reported that a dental assistant experienced an allergic reaction while working with prime&bond active. The symptoms include swollen eyes, redness on the face and coughing. It took between 2-3 hours after working with the product for the symptoms to abate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00013 |
| MDR Report Key | 8116934 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-29 |
| 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 ACTIVE |
| Generic Name | AGENT, TOOTH BONDING, RESIN |
| Product Code | KLE |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-11-21 |
| Model Number | NA |
| Catalog Number | 606.67.343 |
| Lot Number | 1706000231 |
| Device Expiration Date | 2019-06-30 |
| 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 | 2018-11-29 |