BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9988984 · Received April 22, 2020

    Report

    Report Number
    2210968-2020-03389
    Event Type
    Injury
    Date Received
    April 22, 2020
    Report Date
    April 1, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO CLARIFY 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 ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 14, 2011; 883¿886; DOI: ANN VASC SURG 2019; 60: 468¿473 DOI: HTTPS://DOI.ORG/10.1016/J.AVSG.2019.03.006. (B)(4).

    Description of Event or Problem · 1

    TITLE:A REEVALUATION OF THE GRITTI-STOKES (ABOVE-KNEE) AMPUTATION FOR THE NONAMBULATORY PATIENT. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REEVALUATE THE BENEFITS OF A GRITTI-STOKES AMPUTATION (GSA), AS AN ALTERNATIVE TO THE TRADITIONAL ABOVE-KNEE AMPUTATION (AKA), IN PATIENTS WHO ARE NONAMBULATORY OR NOT A CANDIDATE FOR A BELOW-KNEE AMPUTATION (BKA). BETWEEN JANUARY 07, 2016 AND SEPTEMBER 19, 2017, 16 GSAS WERE PERFORMED ON 15 PATIENTS (MALE=14, FEMALE=1; AGE RANGE=28 AND 79 YEARS). DURING THE PROCEDURE, THE DERMIS AND SKIN WERE THEN CLOSED IN THE STANDARD TENSION FREE MANNER USING 2-0 INTERRUPTED VICRYL SUTURES (ETHICON) FOLLOWED BY 2-0 NYLON VERTICAL MATTRESS SUTURES. REPORTED COMPLICATIONS INCLUDED STUMP INFECTION (N=3) WHICH WERE TREATED WITH MINOR WOUND DEBRIDEMENT AND ANTIBIOTICS, WHICH THEN SUBSEQUENTLY HEALED COMPLETELY; WOUND NECROSIS (N=1), REQUIRING OPENING OF THE WOUND SUTURES AND WOUND DEBRIDEMENT. IN CONCLUSION, THIS SMALL SERIES OF GSA¿S HAS YIELDED PROMISING ADVANTAGES INCLUDING POTENTIAL FOR DECREASED BLOOD LOSS AND FEWER COMPLICATIONS IN THE POSTOPERATIVE PERIOD WHEN COMPARED WITH THE STANDARD AKA. RETAINED MUSCLE ATTACHMENTS FACILITATE INCREASED LIMB FUNCTION AND ALLOW USE OF SLIDE JOINT PROSTHETICS, WHICH ARE GAINING POPULARITY FOR AMBULATORY PATIENTS. THE THICKENED SKIN AND SUBCUTANEOUS TISSUES OVERLYING THE PATELLA, AND THE POSTERIOR INCISION HAVE THE POTENTIAL BENEFIT OF PROTECTION AGAINST TRAUMA AND OSTEOMYELITIS SEEN WITH TRADITIONAL AKA, IN WHICH CASE THE OPEN ENDED MEDULLARY BONE IS DEEP TO THE INCISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452455 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention