MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2015-07-09 for GUTTACORE OBTURATOR OVEN HTR-GC manufactured by Dentsply Tulsa Dental Specialties.
[15596225]
In this event it was reported that a doctor received an electrical shock when he plugged a guttacore obturator oven into the electrical socket; no medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
[15735829]
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such, particularly if this issue occurred with a person who is implanted with a pacemaker. This event is reportable per 21 cfr 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
[26855106]
The device was evaluated and found to be within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320721-2015-00007 |
| MDR Report Key | 4910086 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-11 |
| Date Mfgr Received | 2015-08-04 |
| Date Added to Maude | 2015-08-03 |
| 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. |
| 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 | GUTTACORE OBTURATOR OVEN |
| Product Code | EKM |
| Date Received | 2015-07-09 |
| Returned To Mfg | 2015-07-08 |
| Catalog Number | HTR-GC |
| Lot Number | NA |
| 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 TULSA DENTAL SPECIALTIES |
| Manufacturer Address | JOHNSON CITY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |