MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for PASTE FILLER S206100440101 manufactured by Dentsply Maillefer.
[69258446]
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. 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
[69258447]
In this event it was reported that a paste filler separated after initial use. The broken part was retrieved and there is no indication that injury resulted.
Patient Sequence No: 1, Text Type: D, B5
[72580965]
Involved root fillers which were returned have been analyzed. One of them is actually broken at the base of the active part and no material defect was found during analysis of the rupture pattern. The second instrument is unscathed without visible marks of use. Nothing unusual to report was found during dhr review. No unused product have been returned for evaluation. Root causes are not identified. We will track this kind of event and monitor the trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2017-00010 |
| MDR Report Key | 6373761 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-04-12 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-03-02 |
| 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 |
| 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 MAILLEFER |
| Manufacturer Street | CHEMIN DU VERGER 3 |
| Manufacturer City | BALLAIGUES, 1338 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 1338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASTE FILLER |
| Generic Name | INSTRUMENT, FILLING, PLASTIC, DENTAL |
| Product Code | EIY |
| Date Received | 2017-03-02 |
| Returned To Mfg | 2017-01-31 |
| Model Number | NA |
| Catalog Number | S206100440101 |
| Lot Number | 1279419 |
| 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 MAILLEFER |
| Manufacturer Address | CHEMIN DU VERGER 3 BALLAIGUES, 1338 SZ 1338 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |