MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-03 for VERSAH TAPERERD PILOT DRILL VPLTT 1.3MM VPLTT 1.3MM manufactured by Versah, Llc.
| Report Number | 3011117802-2019-00002 |
| MDR Report Key | 8958513 |
| Date Received | 2019-09-03 |
| Date of Report | 2019-08-27 |
| Date of Event | 2019-07-30 |
| Date Mfgr Received | 2019-07-30 |
| Device Manufacturer Date | 2017-04-26 |
| Date Added to Maude | 2019-09-03 |
| 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 | MRS RHONDA ALLEN |
| Manufacturer Street | 2000 SPRING ARBOR ROAD SUITE D |
| Manufacturer City | JACKSON MI 49203 |
| Manufacturer Country | US |
| Manufacturer Postal | 49203 |
| Manufacturer Phone | 8447115585 |
| Manufacturer G1 | VERSAH, LLC |
| Manufacturer Street | 2000 SPRING ARBOR ROAD SUITE D |
| Manufacturer City | JACKSON MI 49203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERSAH TAPERERD PILOT DRILL |
| Generic Name | TAPERED PILOT DRILL |
| Product Code | EJL |
| Date Received | 2019-09-03 |
| Model Number | VPLTT 1.3MM |
| Catalog Number | VPLTT 1.3MM |
| Lot Number | 20041-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERSAH, LLC |
| Manufacturer Address | 2000 SPRING ARBOR ROAD SUITE D JACKSON MI 49203 US 49203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-03 |