MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for THERMAPREP 2 OVEN A017611500200 manufactured by Dentsply Maillefer.
[70339936]
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. This event, therefore, is reportable per 21cfr part 803. On the device there are no mechanic or electric defects detected. The heating elements which are polluted and glued with guttapercha, were cleaned. No further faults were detected.
Patient Sequence No: 1, Text Type: N, H10
[70339937]
It was reported that while using a thermaprep 2 oven, a dental assistant received an electric shock; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8031010-2017-00016 |
| MDR Report Key | 6408987 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-01-27 |
| Date Added to Maude | 2017-03-16 |
| 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 | MRS. HELEN LEWIS |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457551 |
| Manufacturer G1 | UNITRON GROUP BV |
| Manufacturer Street | SCHANSESTRAAT 7 |
| Manufacturer City | IJZENDIJKE ZEELAND, 4515 |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 4515 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERMAPREP 2 OVEN |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2017-03-16 |
| Returned To Mfg | 2017-01-30 |
| Model Number | NA |
| Catalog Number | A017611500200 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-16 |