BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 2944399 · Received February 5, 2013

    Report

    Report Number
    2210968-2013-00797
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A MAMMOPLASTY ON (B)(6) 2012 AND SUTURE WAS USED. THE PATIENT EXPERIENCED A WOUND DEHISCENCE. SHE UNDERWENT A SECONDARY SURGERY WHERE THE WOUND WAS CLOSED WITH A DIFFERENT SUTURE. (B)(4).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT AESTHETIC SURGERY ON (B)(6) 2012 AND SUTURE WAS USED. THE PATIENT STATED THAT THE SUTURE DID NOT ABSORB AND SHE REQUIRED A SECOND SURGERY TO REPLACE THE SUTURE. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48960 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention