EASYDRILL PERFORATOR DM0010FAA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-27 for EASYDRILL PERFORATOR DM0010FAA manufactured by Micromar Industria E Comercio Ltda.

MAUDE Entry Details

• Report Number: 1625507-2019-00128
• MDR Report Key: 9387047
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-11-27
• Date of Report: 2019-11-27
• Date Mfgr Received: 2019-10-29
• Date Added to Maude: 2019-11-27
• 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: NATALIA MATOS
• Manufacturer Street: CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA SER
• Manufacturer City: SAO PAULO,SP 09980-390
• Manufacturer Country: BR
• Manufacturer Postal: 09980-390
• Manufacturer Phone: 140575722
• Manufacturer G1: MICROMAR INDUSTRIA E COMERCIO LTDA
• Manufacturer Street: CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA SER
• Manufacturer City: SAO PAULO,SP 09980-390
• Manufacturer Country: BR
• Manufacturer Postal Code: 09980-390
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EASYDRILL PERFORATOR
• Generic Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Product Code: HBF
• Date Received: 2019-11-27
• Model Number: DM0010FAA
• Catalog Number: DM0010FAA
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• 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 SER SAO PAULO,SP 09980-390 BR 09980-390

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-11-27