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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT LTD. GLASSVAN® BLADE

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NIRAJ INDUSTRIES PVT LTD. GLASSVAN® BLADE Back to Search Results
Model Number 2001T-15
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/26/2018
Event Type  malfunction  
Event Description
The blade broke off inside a patient's brain.
 
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Brand NameGLASSVAN®
Type of DeviceBLADE
Manufacturer (Section D)
NIRAJ INDUSTRIES PVT LTD.
plot 177, sector 25
ballabgarth, faridabad haryana 12100 4
IN 121004
MDR Report Key7221700
MDR Text Key98538452
Report Number1058382-2018-00002
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2001T-15
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2018
Distributor Facility Aware Date01/26/2018
Event Location Hospital
Date Report to Manufacturer01/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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