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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT. LTD. MYCO MED SUPPLIES, INC. SCALPEL BLADE

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NIRAJ INDUSTRIES PVT. LTD. MYCO MED SUPPLIES, INC. SCALPEL BLADE Back to Search Results
Model Number 6000CST-20
Device Problem Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/27/2018
Event Type  malfunction  
Event Description
Avid medical is the manufacturer of a custom procedure tray (aloc002-01 recovery pack, lot: 1324977) that includes the following component: scalpel #20 w/handle s/s, vendor part # 6000cst-20 supplied by (b)(4) and manufactured by niraj industries (b)(4). Avid medical became aware on 01/10/2019 of a complaint which originated by (b)(6) that involved the scalpel that broke within the body while medical professionals were performing a procedure. The complained scalpel #20 w/handle s/s was not available for evaluation, however 10 blades with the same mfg lot number were submitted to the manufacturer for further investigation. Avid medical issued formal complaint # (b)(4) to the supplier (b)(4) concerning the scalpel that broke during a procedure for item no. 6000cst-20, manufacturer lot# 070508. No medical professionals were injured and no patient injury was reported, as this was an organ recovery procedure and the patient was already deceased; however, out of an abundance of caution avid is reporting this event.
 
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Brand NameMYCO MED SUPPLIES, INC.
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
NIRAJ INDUSTRIES PVT. LTD.
177/25 ballabgarh
faridabad haryana
india
Manufacturer (Section G)
AVID MEDICAL INC.
9000 westmont drive
toano VA 23168
Manufacturer Contact
nichole early
9000 westmont drive
toano, VA 23168
8283387568
MDR Report Key8301747
MDR Text Key137014161
Report Number1047429-2019-00002
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6000CST-20
Device Lot Number070508
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? No
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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