BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US MEDCO INC.

    MDR report key: 8154466 · Received December 12, 2018

    Report

    Report Number
    1047429-2018-00011
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 12, 2018
    Manufacturer
    US MEDCO INC.
    Product Code
    GDY
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF CUSTOM CONVENIENCE KIT (REF: (B)(4), MAJOR JOINT TRAY, LOT: 1312031) THAT INCLUDES THE FOLLOWING COMPONENT: LAP SPONGE 18X18 XR 5S NO RING, VENDOR REF# (B)(4), MANUFACTURED BY US MEDCO INC. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2018 ORIGINATED BY (B)(6) OF (B)(6) MEDICAL CENTER. THE COMPLAINT STATES THAT THE SPONGE WAS PLACED ON A PATIENT TO SOAK UP BLOOD DURING PROCEDURE AND THE BLUE LOOP FELL OFF. THEY ALSO STATED THAT THE LOOP WAS FRAYED AND APPEARED TO BE DEFECTIVE. THE LAP SPONGE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS CONSIDERED BIOHAZARDS PROCEEDING USE AND THEREFORE DISPOSED OF IN ACCORDANCE WITH END-USER PROTOCOL. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER US MEDCO INC CONCERNING THE DEFECTIVE LAP SPONGE FOR REF: (B)(4), LOT: 42-17. NO PATIENT INJURY WAS REPORTED. THE SURGERY WAS NOT DELAYED AND NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED AS A RESULT OF THE DEFECTIVE SPONGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996073 US MEDCO INC. LAPAROTOMY SPONGE GDY US MEDCO INC. 1818 W1900 42-17

    Patients

    Seq Age Sex Outcome Treatment
    1