BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1942548 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01737
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES SUBMITTED FOR THE SAME PT AS TWO SITES OF INFECTION WERE PRESENT. SEE ALSO MEDWATCH 2210968-2010-01740.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BILATERAL REMOVAL AND REPLACEMENT OF BREAST IMPLANT WITH LIPOSUCTION ON (B)(6) 2010 AND SUTURE WAS USED. THE PT DEVELOPED A SUPERFICIAL BREAST INFECTION ON (B)(6) 2010. CULTURES WERE TAKEN, RESULTS ARE UNK. ANTIBIOTICS WERE PRESCRIBED AND THE PT IS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CCM913

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention