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 2018-03-16 for PRIME & BOND ACTIVE 606.67.345 manufactured by Dentsply Detrey Gmbh.
[102706543]
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. This report is for the second patient. Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4). The device was evaluated and found to be within specification. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
[102706544]
It was reported that a dentist used prime & bond active on two patients and within 10 minutes after treatment, their skin burned and their lips were swollen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00002 |
| MDR Report Key | 7345803 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-03-16 |
| 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. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494229 |
| 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 | 2018-03-16 |
| Returned To Mfg | 2018-02-26 |
| Model Number | NA |
| Catalog Number | 606.67.345 |
| Lot Number | 1704000549 |
| 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 | 2018-03-16 |