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 2015-08-12 for GUTTAFUSION OBTURATORS V041545000000 manufactured by Dentsply Vdw Gmbh.
[23989391]
Additional information is being requested. However, because this event could result in permanent damage to a body function/structure as evidenced by previous reported events with similar devices, this event meets the criteria for reportability per 21 cfr part 803. The returned device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
[23989392]
In this event it was reported that while using guttafusion all root canals were overfilled. Patient/case details are not available as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611053-2015-00031 |
| MDR Report Key | 5006589 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-08-12 |
| Date of Report | 2015-07-13 |
| Date Mfgr Received | 2015-07-13 |
| 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 CENTER 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 | 0 |
| Brand Name | GUTTAFUSION OBTURATORS |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2015-08-12 |
| Returned To Mfg | 2015-07-13 |
| Catalog Number | V041545000000 |
| Lot Number | GF14400069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY VDW GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-12 |