MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-09-11 for HALL ORALMAX ELITE HIGH SPEED DRILL PRO7000DE manufactured by Conmed Corporation.
[119865511]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[119865512]
The customer reported that the pro7000de, hall oralmax drill, allegedly " became instantly hot and burnt the palm and index finger of the assistant. The unit will be sent in for repair. " further assessment cannot be performed due to physicians office being closed. This report is being raised on the basis of a reported injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017294-2018-00147 |
| MDR Report Key | 7865257 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-09-11 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-08-16 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2018-09-11 |
| 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 | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL ORALMAX ELITE HIGH SPEED DRILL |
| Generic Name | HIGH SPEED DRILL |
| Product Code | DZA |
| Date Received | 2018-09-11 |
| Returned To Mfg | 2018-10-03 |
| Catalog Number | PRO7000DE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-11 |