BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3913906 · Received July 3, 2014

    Report

    Report Number
    2210968-2014-08672
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE AND ONE SECTION OF SUTURE WAS RETURNED FOR EVALUATION. A VISUAL EXAMINATION FOUND THE NEEDLE WAS DETACHED FROM THE SUTURE AND CONTAINED BROKEN SUTURE IN THE BARREL. THE SUTURE ITSELF WAS EXTREMELY BRITTLE AND COULD NOT BE HANDLED WITHOUT BREAKING, WHICH IS A CHARACTERISTIC OF SIGNIFICANT DEGRADATION INDICATING THAT THE INTEGRITY OF THE LAMINATED FOIL PACKAGING WAS COMPROMISED. THE LAMINATED FOIL PACKAGING WAS NOT RETURNED FOR EVALUATION. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389636 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GLM855

    Patients

    Seq Age Sex Outcome Treatment
    1