BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYCO MED SUPPLIES, INC.

    MDR report key: 8301747 · Received February 4, 2019

    Report

    Report Number
    1047429-2019-00002
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    December 27, 2018
    Report Date
    February 4, 2019
    Manufacturer
    NIRAJ INDUSTRIES PVT. LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94685 MYCO MED SUPPLIES, INC. SCALPEL BLADE GES NIRAJ INDUSTRIES PVT. LTD. 6000CST-20 070508

    Patients

    Seq Age Sex Outcome Treatment
    1