BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8847831 · Received July 31, 2019

    Report

    Report Number
    2210968-2019-84946
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    July 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. CITATION: ACTA ORTHOP. BELG. 2005; 71: 309-314. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : DAY CASE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION: A STUDY OF 51 CONSECUTIVE PATIENTS." AUTHOR : SUMEDH TALWALKAR, SRI KAMBHAMPATI, DENNIS DE VILLIERS, ROSEMARY BOOTH, ANDREW LANG STEVENSON. CITATION: ACTA ORTHOP. BELG. 2005; 71: 309-314. THE AUTHORS PROSPECTIVELY ASSESSED 51 ARTHROSCOPY ASSISTED ANTERIOR CRUCIATE RECONSTRUCTIONS (45 MALE AND 6 FEMALE PATIENTS; AGE RANGE: 18 TO 52 YEARS OLD) DONE OVER TWO YEARS AS DAY CASES. DURING THE SURGICAL PROCEDURE, THE SUBCUTANEOUS TISSUE AND SKIN WERE CLOSED WITH VICRYL 2-0 (ETHICON) AND VICRYL 3-0 (ETHICON) RESPECTIVELY. REPORTED COMPLICATIONS INCLUDED SEVERE PAIN (N-1), CALF TENDERNESS (N-2), HEMARTHROSIS (N-1) THAT HAD TO BE ASPIRATED DUE TO AN OOZING WOUND, AND STITCH ABSCESS (N-1). THE STUDY CONFIRMED THAT DAY CASE ANTERIOR CRUCIATE LIGAMENT SURGERY IS FEASIBLE. THE ROLE OF PROPER PATIENT COUNSELLING AND SELECTION PREOPERATIVELY CANNOT BE OVEREMPHASIZED. THE AUTHORS HAVE DEMONSTRATED THAT OUTPATIENT ACL SURGERY IS A SAFE AND PRACTICAL PROCEDURE. A LARGE MAJORITY OF THE PATIENTS INCLUDED IN THE TRIAL EXPRESSED SATISFACTION WITH HAVING THE PROCEDURE DONE ON AN OUTPATIENT BASIS AND STATED THAT THEY WOULD CHOOSE THIS PROCEDURE AGAIN IN THE FUTURE IF IT WERE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639312 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention