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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: M/S NIRAJ INDUSTRIES PVT LTD. GLASSVAN SURGICAL BLADE

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M/S NIRAJ INDUSTRIES PVT LTD. GLASSVAN SURGICAL BLADE Back to Search Results
Catalog Number 2001T-15
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Event Description
It was reported that the #15 surgical blade broke during the removal of impacted 3rd molars of the female patient. The broken blade (fragment) was quickly recovered from the patient's mouth and no further medical intervention or additional treatment was needed due to this issue.
 
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Brand NameGLASSVAN
Type of DeviceSURGICAL BLADE
Manufacturer (Section D)
M/S NIRAJ INDUSTRIES PVT LTD.
plot 177, sector 25
ballabgarth, 12100 4
IN 121004
MDR Report Key7531889
MDR Text Key108982832
Report Number1058382-2018-00004
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 Distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Catalogue Number2001T-15
Device Lot Number171611AC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2018
Distributor Facility Aware Date05/11/2018
Device Age6 MO
Event Location Other
Date Report to Manufacturer05/16/2018
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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