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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 Code Available (3191)
Event Date 12/20/2017
Event Type  malfunction  
Event Description
It was reported that blades have been breaking, and in some cases breaking inside the patient while being used.
 
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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
Manufacturer (Section G)
NIRAJ INDUSTRIES PVT. LTD.
932, sector-68, imt
faridabad, haryana 12100 4
IN 121004
Manufacturer Contact
rajiv nath
932, sector-68, imt
faridabad, haryana 12100-4
IN   121004
MDR Report Key7241951
MDR Text Key194149466
Report Number8040409-2018-00001
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2001T-15
Device Lot Number171008AC
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/22/2018
Distributor Facility Aware Date01/18/2018
Event Location Other
Date Report to Manufacturer01/22/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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