BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 4222809 · Received November 4, 2014

    Report

    Report Number
    2210968-2014-15256
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT MICROSURGICAL SPERM EXTRACTION ON (B)(6) 2014 AND SUTURE WAS USED TO CLOSE THE SKIN. THE PATIENT DEVELOPED A WOUND DEHISCENCE ON (B)(6) 2014. THE WOUND WAS ALLOWED TO HEAL BY SECONDARY INTENTION. THERE WAS NO SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SCROTAL SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED TO CLOSE THE INCISION. THE PATIENT DEVELOPED A WOUND DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707294 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other