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 2015-08-15 for AH PLUS JET REFILL KIT 60620118 manufactured by Dentsply Detrey Gmbh.
[23217616]
Additional information has been requested, but is not yet available. Based on the chemical and physical properties of paste b, it can be concluded that patients where paste b of ah plus was used as a root canal sealer only may experience issues up to and including loss of the treated tooth. It is recommended that the patients treated with the faulty syringe be examined clinically and radiologically and consider retreatment of the affected root canal fillings. Therefore, because medical intervention may be required, this event is reportable per 21 cfr part 803. Investigation found a manufacturing error that resulted in both chambers of the syringe to be filled with paste b.
Patient Sequence No: 1, Text Type: N, H10
[23217617]
In this event it was reported that only paste b was coming out of an ah plus jet syringe. The syringe was used on an unknown number of patients. No patient details are available as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
[25887514]
After a comprehensive investigation, it was found that only a single syringe was faulty and the complete lot was not affected. This issue was caused by a human error during the set-up of the equipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010638-2015-00008 |
| MDR Report Key | 5008538 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-08-15 |
| Date of Report | 2015-07-14 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-08-17 |
| Date Added to Maude | 2015-08-17 |
| 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 | 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 REFILL KIT |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2015-08-15 |
| Returned To Mfg | 2015-07-27 |
| Catalog Number | 60620118 |
| Lot Number | 1412000549 |
| Device Expiration Date | 2016-11-30 |
| 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. Other | 2015-08-15 |