BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 11325786 · Received February 12, 2021

    Report

    Report Number
    2210968-2021-01425
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    July 25, 2019
    Report Date
    January 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? 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 VIA A JOURNAL ARTICLE: TITLE: AN UPDATE ON OXIDIZED REGENERATED CELLULOSE (FIBRILLAR) IN REDUCING POSTOPERATIVE CORPORAL BLEEDING FOLLOWING INFLATABLE PENILE PROSTHESIS SURGERY AUTHORS: AVERY R. WOLFE, MICHAEL T. DAVENPORT, ALEXANDER T. ROZANSKI, NABEEL A. SHAKIR, ELLEN E. WARD, MARY L. WEST, AND ALLEN F. MOREY. CITATION: TRANSL ANDROL UROL 2020;9(1):43-49; DOI: 10.21037/TAU.2019.08.05. THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE USE OF OXIDIZED REGENERATED CELLULOSE (ORC) AND ITS EFFECT ON POSTOPERATIVE DRAIN OUTPUT AND POSTOPERATIVE PATIENT-INITIATED PHONE CALLS FOLLOWING INFLATABLE PENILE PROSTHESIS (IPP) SURGERY. BETWEEN APR 2013 TO FEB 2019, 274 MEN WITH A MEDIAN AGE OF 67 YEARS (RANGE 59-71) AND MEDIAN BMI OF 29 (KG/M2), UNDERWENT IPP IMPLANTATION OR REVISION. THE OUTCOMES WERE COMPARED AMONGST CONSECUTIVE CASES WITH ORC SURGICEL FIBRILLAR (ETHICON) (APRIL 2016 TO FEBRUARY 2019) AND WITHOUT ORC (APRIL 2013 TO MARCH 2016). DURING CORPOROTOMY CLOSURE, VASCULAR FORCEPS WERE USED TO PLACE 2¿3 ORC PLEDGETS FASHIONED FROM A 1×2-INCH FIBRILLAR (ETHICON) PACKAGE INTO BOTH CORPORAL DEFECTS, POSITIONED TO DIRECTLY OVERLAY THE FULLY DEFLATED IPP CYLINDERS. THE CORPOROTOMIES WERE THEN CLOSED OVER THE ABSORBABLE ORC PLEDGETS USING A SERIES OF PRE-PLACED 2-0 PDS TRACTION SUTURES. FIVE PATIENTS IN THE ORC GROUP UNDERWENT IPP EXPLANTATION DURING THE STUDY PERIOD DUE TO DEVICE INFECTION (N=5). INCORPORATION OF ORC DURING CORPOROTOMY CLOSURE THUS DID NOT PRESENT ANY INCREASED RISK FOR DEVICE INFECTION OR LATER EXPLANTATION. IT IS WELL-ESTABLISHED THAT INCREASED POSTOPERATIVE FLUID ACCUMULATION WITHIN THE SCROTUM IS A SIGNIFICANT RISK FACTOR FOR DEVICE INFECTION FOLLOWING IPP IMPLANTATION. BY REDUCING POSTOPERATIVE DRAIN OUTPUT, ORC PLACEMENT DURING CORPOROTOMY CLOSURE IS AN EFFECTIVE TOOL TO POTENTIALLY REDUCE SCROTAL HEMATOMA-RELATED COMPLICATIONS IN IPP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216802 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention