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 2015-09-29 for AH PLUS JET 60620118 manufactured by Dentsply Detrey Gmbh.
[27052157]
Therefore, because intervention was required, this event is reportable per 21 cfr part 803. The device is available for evaluation, though results are not available as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[27052158]
It was reported that after endodontic treatment with ah plus jet on tooth # 36 a patient experienced strong pain that would not yield to painkillers, nor to anti-inflammatory drugs. Once unsealing occurred, the pain disappeared. The dentist used calcium hydroxide and performed new sealing with a eugenate based cement.
Patient Sequence No: 1, Text Type: D, B5
[31097509]
The device 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
| Report Number | 8010638-2015-00011 |
| MDR Report Key | 5111304 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-09-29 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-07-07 |
| Date Mfgr Received | 2015-10-12 |
| Date Added to Maude | 2015-09-29 |
| 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 | 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 | 2015-09-29 |
| Returned To Mfg | 2015-09-28 |
| Model Number | NA |
| Catalog Number | 60620118 |
| Lot Number | 1503000833 |
| Device Expiration Date | 2017-02-28 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| 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. Required No Informationntervention | 2015-09-29 |