BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 4221305 · Received November 3, 2014

    Report

    Report Number
    2210968-2014-15185
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A MOHS PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS NOTED DURING THE 2ND OR 3RD POST OP VISIT THAT THE PATIENT HAD DEVELOPED AN ABSCESS. THE ABSCESS WAS OPENED AND DRAINED. ANTIBIOTIC OINTMENT WAS PRESCRIBED. THE ABSCESS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701785 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention