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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-10
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
Event Type  malfunction  
Event Description
Blade broke off in patient, was able to recover.
 
Manufacturer Narrative
The following sections referenced below were corrected: the 'date of event' was inadvertently recorded incorrectly on the initial report of this mdr. The date was changed from (b)(6) 2018 to the correct date of (b)(6) 2018 (as reflected in this follow-up report). Providing information about the 'operator of device; physician selected. The initial reporter of this event to the importer did not provided whether they reported this event being discussed to the fda; therefore, 'unknown' was selected in this section. Providing clarification of the date the 'report sent to manufacturer'; date changed from 03/27/2018 to the correct date of 03/29/2018 (as reflected in this follow-up report). This mdr will be updated as pertinent information is received about this event.
 
Event Description
Blade broke off in patient, was able to recover.
 
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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 Key7375137
MDR Text Key103661115
Report Number1058382-2018-00003
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
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model Number2001T-10
Device Lot Number160908AC
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 FDA03/27/2018
Distributor Facility Aware Date03/27/2018
Device Age20 MO
Event Location Hospital
Date Report to Manufacturer03/29/2018
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?
Type of Device Usage

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