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 2019-03-27 for AH PLUS ROOT CANAL SEALER 606.20.110 manufactured by Dentsply Detrey Gmbh.
[139999202]
However, there has been a previous report received where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction 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. If the picture the customer sent in was followed the complaint would not meet spec. But technically it is impossible that this mix-up of lots did occur. The customer received both lots. The root cause of the mix-up is likely to be at the customers end. A dhr review was conducted with no discrepancies noted.
Patient Sequence No: 1, Text Type: N, H10
[139999203]
It was reported that a package of ah plus contained two tubes of the same paste. There was no report of injury to the patient and no report of medical/surgical intervention resulting from use of this product as the problem was apparently discovered before use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010638-2019-00005 |
| MDR Report Key | 8455840 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-27 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2019-03-27 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| 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 ROOT CANAL SEALER |
| Generic Name | RESIN, ROOT CANAL FILLING |
| Product Code | KIF |
| Date Received | 2019-03-27 |
| Returned To Mfg | 2019-02-26 |
| Model Number | NA |
| Catalog Number | 606.20.110 |
| Lot Number | 1802000893 |
| 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 | 2019-03-27 |