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 2018-03-23 for AH PLUS JET 606.20.115 manufactured by Dentsply Detrey Gmbh.
[103416024]
There has been a previous report received where overfilling a root canal resulted in a serious injury. Therefore, it must be presumed that recurrence of this issue could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. The return sample was empty. A retain sample was evaluated and found to be within specification. Also, a dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
[103416025]
A complaint was received regarding the amount of material in one of the tubes of ah plus jet. While reviewing the x-ray of a patient in that complaint, it was found that a dentist had overfilled a patient's canal with ah plus jet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2018-00003 |
| MDR Report Key | 7366870 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-03-23 |
| 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 | AH PLUS JET |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2018-03-23 |
| Returned To Mfg | 2018-03-09 |
| Model Number | NA |
| Catalog Number | 606.20.115 |
| Lot Number | 1704000447 |
| Device Expiration Date | 2019-03-01 |
| 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 | 2018-03-23 |