BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD

    MDR report key: 7046108 · Received November 20, 2017

    Report

    Report Number
    2210968-2017-71341
    Event Type
    Injury
    Date Received
    November 20, 2017
    Report Date
    October 23, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ¿ DOES THE SURGEON BELIEVE THAT VICRYL PLUS SUTURES CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: ABSCESS, PROLONGED HOSPITAL STAY? 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 VICRYL PLUS SUTURES? WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? WAS THE PATIENT TREATMENT ALTERED IN ANYWAY DUE TO THE PROLONGED SURGERY TIME? IF YES, PLEASE EXPLAIN. CITATION: CIR PEDIATR 2008; 21(4): 199-202.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE THAT THE PATIENT UNDERWENT APPENDECTOMY ON UNKNOWN DATE BETWEEN 3/2006 AND 12/2006 AND SUTURE WAS USED ON THE ABDOMINAL WALL. THE STUDY WAS CONDUCTED FOR A PERIOD OF 18 MONTHS, DIVIDED INTO 2 CONSECUTIVE PERIODS OF 9 MONTHS EACH, TO DETERMINE IF INSERTING THE ANTIBACTERIAL ELEMENTS OF PROVEN USE AND EFFECTIVENESS INTO THE SURGICAL WOUNDS WOULD REDUCE THE INCIDENCE OF WALL ABSCESSES. THIS IS A PROSPECTIVE CLINICAL STUDY EVALUATING THE INCIDENCE OF ABDOMINAL WALL ABSCESS UNDER DIFFERENT SURGICAL MANAGEMENT. THE PATIENT POSSIBLY DEVELOPED ABSCESS OF THE ABDOMINAL WALL WITH AN AVERAGE EXTENDED HOSPITAL STAY OF 12.5 DAYS. THE ADDED USE OF SUTURES COVERED WITH ANTISEPTIC HAS PROVED TO BE EFFECTIVE IN THIS SERIES TO STATISTICALLY SIGNIFICANTLY REDUCE THE INCIDENCE OF WALL ABSCESSES, AND ALONG WITH IT THE AVERAGE HOSPITAL STAY. ADDITIONAL INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825546 VICRYL PLUS POLYGLACTIN 910 SUTURE UNKNOWN PROD SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization