BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3253987 · Received July 30, 2013

    Report

    Report Number
    2210968-2013-15043
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VETERINARIAN THAT WHILE DISPENSING THE PRODUCT ON (B)(6) 2013, THE NEEDLE PULLED OFF THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355384 MONOCRYL PLUS SUTURE SUTURES - ABSORBABLE GAM ETHICON INC. UNK GB5BCHV

    Patients

    Seq Age Sex Outcome Treatment
    1