BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICEL* 5X7.5CM

    MDR report key: 11064275 · Received December 23, 2020

    Report

    Report Number
    2210968-2020-10233
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    January 1, 2018
    Report Date
    December 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HOW WAS THE PRODUCT PURCHASED? (B)(4) TURKISH LIRAS FOR EACH IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? NO. IS THERE ANY INDICATION OF THE SOURCE? NO. BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? LOTS DO NOT BELONG TO ANY JNJ PRODUCT. WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? YES BUT THERE IS NO PATIENT CONSEQUENCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ONE POUCH WITH TYVEK AND ORC OF PRODUCT CODE 1903GB AND LOT NUMBER 3931247 WAS RECEIVED FOR EVALUATION. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE DEVICE RECEIVED WAS NOT IN ITS ORIGINAL PACKAGING AND THERE WAS ONLY ONE POUCH, NOT THE FULL BOX. THE PRODUCT WAS MANIPULATED AS IT WAS A BIT FOLDED BUT THERE WAS NO DAMAGE SUCH AS TEARS OR HOLES ON IT. MANY DISCREPANCIES WERE FOUND DURING THE INVESTIGATION SPECIFICALLY REGARDING THE PACKAGING AND SURGICEL PRODUCT ITSELF. THEREFORE, BASED ON THE PRODUCT EVALUATION, THE COMPLAINT IS CONFIRMED. NO NONCONFORMANCE WILL BE OPENED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE COMPANIES DEALERS SAW THAT THERE WAS A PRODUCT, ABSORBABLE HEMOSTAT, FROM A DIFFERENT SOURCE IN A HOSPITAL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532237 SURGICEL* 5X7.5CM AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC. 3931247

    Patients

    Seq Age Sex Outcome Treatment
    1