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 2019-10-24 for UNKNOWN - INSTRUMENT/TOOL manufactured by Nobel Biocare Ab - Kga.
| Report Number | 9611993-2019-15615 |
| MDR Report Key | 9232359 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-10-24 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-23 |
| Date Mfgr Received | 2019-09-12 |
| Date Added to Maude | 2019-10-24 |
| 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. DEADRIENNE JANSSEN |
| Manufacturer Street | KOZAKKENBERG 4 |
| Manufacturer City | BELFELD, LIMBURG 5915DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 5915DL |
| Manufacturer G1 | NOBEL BIOCARE AB - KGA |
| Manufacturer Street | DIMBOVGEN 2 |
| Manufacturer City | KARLSKOGA, SE-691 5 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-69 1 51 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN - INSTRUMENT/TOOL |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-10-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOBEL BIOCARE AB - KGA |
| Manufacturer Address | DIMBOVGEN 2 KARLSKOGA, SE-691 5 SW SE-69 1 51 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-24 |