MAUDE Adverse Event Report: MICROMAR INDÚSTRIA E COMÉRCIO LTDA EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

While resident was using perforator, it malfunctioned.Patient was not injured.Was not used on field.

• Brand Name: EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDÚSTRIA E COMÉRCIO LTDA
• MDR Report Key: 10670493
• MDR Text Key: 211054948
• Report Number: 10670493
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/13/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA