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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.
 
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.
 
Manufacturer Narrative
The manufacturer has investigated this issue on the control samples and samples provided by the complainant of the same batch number (171611ac).The reported problem could not be established on examination of retained samples and related records of batch number 171611ac.The device characteristics which can induce breakage of blade have been observed within specifications.34 unused samples provided by the complainant are also found within the specifications with regard to the parameters which can induce blade breakage (sharpness, hardness, stiffness and fitment of blades).Samples evaluation reports are enclosed for your ready reference.We have closed the complaint based on the result of the manufacturer's investigation.We consider this report closed.
 
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Brand Name
GLASSVAN
Type of Device
SURGICAL 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
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was 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 Expiration Date11/01/2022
Device Catalogue Number2001T-15
Device Lot Number171611AC
Was Device Available for Evaluation? 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
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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