MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-06-03 for AH PLUS JET SEALER 60620115 manufactured by Dentsply Detrey Gmbh.
[5839539]
In this event it was reported that a patient had pain several days after treatment with ah plus jet. The dentist removed the material from the patient's root canal and found it was still fluid. One day after the material was removed, the patient's pain disappeared.
Patient Sequence No: 1, Text Type: D, B5
[13504014]
Upon review of the dentist's technique, it was found that he did not follow the dfu and bleed the material before use. Therefore, because intervention was required, this event is reportable per 21 cfr part 803. 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
| Report Number | 8010638-2015-00005 |
| MDR Report Key | 4821450 |
| Report Source | 01,05 |
| Date Received | 2015-06-03 |
| Date of Report | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2015-06-08 |
| 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 | SUSQUEHANNA COMMERCE CTR W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AH PLUS JET SEALER |
| Generic Name | ROOT CANAL FILLING RESIN |
| Product Code | KIF |
| Date Received | 2015-06-03 |
| Returned To Mfg | 2015-05-12 |
| Catalog Number | 60620115 |
| Lot Number | 1408000785 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | KONSTANZ GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-03 |