BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3894790 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08208
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE LOT NUMBERS: LOT HBM487; LOT HB5345.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED TO CLOSE A HORIZONTAL INCISION IN THE PATIENTS ABDOMINAL FASCIA. THE INCISION WAS CLOSED IN KNOTTED SUTURE THROUGH THE FASCIA AND THE OPERATION WAS COMPLETED SUCCESSFULLY. LATER THAT EVENING, THE CLOSED INCISION OPENED AND A RE-OPERATION WAS PERFORMED. THE SURGEON OBSERVED DURING RE-OPERATION, THAT THE KNOTTED SUTURE HAD COME UNTIED. THE SURGEON OPINED THAT DUE TO THE BODY SIZE OF THE PATIENT THERE MIGHT HAVE BEEN MORE TENSION ON THE LIGATION PART THAN USUAL OR THE SUTURE MAY HAVE SPLIT THE FASCIA MOVING THE KNOT WHICH CAUSED THE UNTYING OR THE KNOT WAS NOT APPROPRIATELY TIED IN THE FIRST PLACE. CURRENTLY, THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369966 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention