BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR

    MDR report key: 12024663 · Received June 18, 2021

    Report

    Report Number
    2210968-2021-05662
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    January 1, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    UDI-DI
    10705031237506
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ALL OF THE SURGICEL POWDER WAS USED, AND IRRIGATION WAS NOT PERFORMED. THE PATIENT, WHO UNDERWENT A HYSTERECTOMY HAD CONSIDERABLE AMOUNT OF GI ISSUES, HAD A LOT OF INFLAMMATION ON THE BOWEL AND REQUIRED AN NG TUBE. DR. WILLET STRONGLY FEELS THAT THE SURGICEL POWDER IS WHAT CAUSED THE PATIENT¿S GI ISSUES, AND THAT THE POWDER GOT ON THE BOWEL CREATING ISSUES WITH THE BOWEL (INFLAMMATION). THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT IS THE PROCEDURE DATE? WHAT DATE DID THE ABSCESS OCCUR ON? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THE ABSCESS (RE-OPERATION; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED; OTHER MEDICATION PRESCRIBED)? IF SO, PLEASE CLARIFY. WHAT IS THE MOST CURRENT PATIENT STATUS? CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2021 AND ABSORBABLE HEMOSTAT WAS USED. POST-OPERATIVELY THE PATIENT EXPERIENCED AN ABSCESS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920125 SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC. 3013SP 10705031237506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention