MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-30 for X-SMART IQ BASIC STARTER KIT (INCLUDES CONTRA ANGLE) A105400000000 manufactured by Tulsa Dental Products Llc.
| Report Number | 8031010-2019-00153 |
| MDR Report Key | 9136649 |
| Date Received | 2019-09-30 |
| Date of Report | 2019-10-22 |
| Date Mfgr Received | 2019-09-27 |
| Date Added to Maude | 2019-09-30 |
| 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 | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178494424 |
| Manufacturer G1 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
| Manufacturer Street | VIA SAN DONATO 1 |
| Manufacturer City | PISTOIA, 51100 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 51100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-SMART IQ BASIC STARTER KIT (INCLUDES CONTRA ANGLE) |
| Generic Name | CONTROLLER, FOOT, HANDPIECE AND CORD |
| Product Code | EBW |
| Date Received | 2019-09-30 |
| Returned To Mfg | 2019-08-26 |
| Model Number | NA |
| Catalog Number | A105400000000 |
| 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 | TULSA DENTAL PRODUCTS LLC |
| Manufacturer Address | 608 ROLLING HILLS DRIVE JOHNSON CITY TN 37604 US 37604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-30 |