MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-08-19 for DETREY CONDITIONER 36 60615208 manufactured by Dentsply Detrey.
[2247307]
In this event it was reported that two pts experienced burning, white discoloration and ablation of the gingival immediately after contact with detrey conditioner 36. Both pts were treated with kamistad gel. One pt stated the pain occurred for several minutes. The other pt returned to the dentist's office two days later and he was treated with volon-a at that time.
Patient Sequence No: 1, Text Type: D, B5
[9257682]
It is possible that prolonged skin / oral mucosa contact with phosphoric acid could result in burning, irritation, sensitization, and other symptoms. The directions for use clearly address the possible effects of oral mucosa and skin contact and provide preventive and corrective measures. Furthermore, this event is related to use-error and is not the result of a malfunction of the syringe. Please note that the device involved is not sold in the us. However, it is considered similar to devices that are based on its composition and syringe delivery mechanism. Therefore, because a serious history injury occurred, this event meets the criteria for reportability per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2011-00011 |
| MDR Report Key | 2227005 |
| Report Source | 01,05 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-07-22 |
| Date Mfgr Received | 2011-07-22 |
| Date Added to Maude | 2011-09-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST., STE. SUSQUEHANNA COMMERCE CTR W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | DENTSPLY DETREY |
| Manufacturer Street | DETREY STRASSE 1 |
| Manufacturer City | KONSTANZ D-78467 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78467 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DETREY CONDITIONER 36 |
| Product Code | EBC |
| Date Received | 2011-08-19 |
| Returned To Mfg | 2011-07-26 |
| Catalog Number | 60615208 |
| Lot Number | 1004000712 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY DETREY |
| Manufacturer Address | DETREY STRASSE 1 KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-19 |