BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 7068497 · Received November 29, 2017

    Report

    Report Number
    2210968-2017-71488
    Event Type
    Injury
    Date Received
    November 29, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO SYMPTOMS OF BLEEDING, INFECTION, AND RENAL INEFFICIENCY DESCRIBED IN THE ARTICLE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR DEVICES USED? 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. CITATION: EUROPEAN UROLOGY 2006; 49:660-665. DOI:10.1016/J.EURURO.2006.02.001.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (LAPAROSCOPIC PARTIAL NEPHRECTOMY: CONTEMPORARY TECHNIQUE AND OUTCOMES) THAT THE PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL NEPHRECTOMY. IN THE SURGICAL TECHNIQUE, THE COLLECTING SYSTEM IS SUTURE REPAIRED WITH A RUNNING SUTURE ON NEEDLE. RENAL PARENCHYMAL REPAIR IS PERFORMED WITH 1-0 POLYGLACTIN ON A GS-25 NEEDLE. THREE TO 5 INTERRUPTED SUTURES ARE PLACED OVER A PRE-PREPARED ABSORBABLE HEMOSTAT BOLSTER THAT HAS BEEN POSITIONED OVER THE CUT SURFACE OF THE KIDNEY. FLOSEAL IS APPLIED TO THE CUT RENAL PARENCHYMAL SURFACE UNDERNEATH THE BOLSTER. ANOTHER HEM-O-LOK CLIP IS APPLIED TO THE SUTURE FLUSH WITH THE OPPOSITE RENAL SURFACE, COMPRESSING THE KIDNEY. THE SUTURE IS THEN TIGHTLY TIED ACROSS THE BOLSTER, MAINTAINING ADEQUATE PARENCHYMAL COMPRESSION. POSTOPERATIVELY, THE PATIENT MAY HAVE EXPERIENCED BLEEDING, RENAL INSUFFICIENCY, AND INFECTION. TREATMENT OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847853 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1