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 2018-01-15 for THERMAPREP PLUS OVEN A017622000000 manufactured by Dentsply Maillefer.
[97414795]
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. Evaluation found the power cord is unsheathed and there is a risk of short circuit. Additional information regarding the patient outcome has been requested and will be submitted as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
[97414796]
It was reported that there was an electric shock due to a cable defect with a thermaprep plus oven. The outcome of the event is unknown as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
[113800352]
Multiple unsuccessful attempts were made to obtain the patient outcome.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8031010-2017-00142 |
| MDR Report Key | 7190034 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-01-15 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-01-17 |
| Date Added to Maude | 2018-01-15 |
| 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 | 7178494229 |
| 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 | 3 |
| Brand Name | THERMAPREP PLUS OVEN |
| Generic Name | GUTTA-PERCHA |
| Product Code | EKM |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-05 |
| Model Number | NA |
| Catalog Number | A017622000000 |
| Lot Number | NA |
| 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 | 2018-01-15 |