MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-02 for LEGEND TAPERED DISSECTING TOOL F2/8TA23 manufactured by Mdt Powered Surgical Solutions.
| Report Number | 1625507-2020-00027 |
| MDR Report Key | 9777347 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal | 761373291 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Street | 4620 N BEACH ST |
| Manufacturer City | FORT WORTH TX 76137 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND TAPERED DISSECTING TOOL |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | HBE |
| Date Received | 2020-03-02 |
| Model Number | F2/8TA23 |
| Catalog Number | F2/8TA23 |
| Lot Number | H5572134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 N BEACH ST FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |