BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3851828 · Received June 5, 2014

    Report

    Report Number
    2210968-2014-07186
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    November 25, 2013
    Report Date
    May 21, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): A FRAGMENT OF SUTURE AND A NEEDLE EPARATED FROM THE PRODUCT WAS RETURNE FOR EVALUATION. THE NEEDLE RETURNED DID NOT CORRESPOND WITH THE PRODUCT THAT WAS REPORTED. VISUAL ANALYSIS PERFORMED ON THE RETURNED FRAGMENT OF SUTURE SHOWED THAT CLAMPING MARKS WERE OBSERVED. MARKS CHARACTERISTIC OF A CUT CAUSED BY A SURGICAL INSTRUMENT WERE ALSO OBSERVED. TENSILE STRENGTH TESTS WERE PERFORMED ON THE SUTURE FRAGMENT AND ALL RESULTS SHOWED NO DEVIATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6) 2013 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328519 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1