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 2020-02-13 for EASYDRILL PERFORATOR DM0010FAA manufactured by Micromar Industria E Comercio Ltda.
| Report Number | 1625507-2020-00021 |
| MDR Report Key | 9708760 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-01-03 |
| Date Added to Maude | 2020-02-13 |
| 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 | NATALIA MATOS |
| Manufacturer Street | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA S |
| Manufacturer City | SAO PAOLO,SP 09980-39 |
| Manufacturer Country | BR |
| Manufacturer Postal | 09980-39 |
| Manufacturer Phone | 140575722 |
| Manufacturer G1 | MICROMAR INDUSTRIA E COMERCIO LTDA |
| Manufacturer Street | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA S |
| Manufacturer City | SAO PAOLO,SP 09980-39 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 09980-39 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYDRILL PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) |
| Product Code | HBF |
| Date Received | 2020-02-13 |
| Model Number | DM0010FAA |
| Catalog Number | DM0010FAA |
| Lot Number | 1448/18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROMAR INDUSTRIA E COMERCIO LTDA |
| Manufacturer Address | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA S SAO PAOLO,SP 09980-39 BR 09980-39 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |