BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3894776 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08206
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4) - A REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY EVALUATED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT FEMORAL ENDARTERECTOMY ON (B)(6) 2014 AND SUTURE WAS USED ON THE SUBCUTANEOUS TISSUE. DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE PREMATURELY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370250 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1