BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 2832305 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07289
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE FIRST SURGERY WAS FOR DIASTASIS RECTI AND UMBILICAL HERNIA ON (B)(6) 2011 AND THE SECOND SURGERY WAS FOR LUMP AND PAIN IN ABDOMEN ON (B)(6) 2012. THE PATIENT HAS NO HISTORY OF INFECTIONS, BUT STILL HAS BURNING, SWELLING, REDNESS AND PAIN IN THE LOWER ABDOMEN WHICH IMPROVED WITH ANTIBIOTICS. THE SURGEON DIAGNOSED THE PATIENT WITH MICRO-ABSCESSES/MINI-INFECTIONS AROUND THE SUTURE ON THE RIGHT SIDE OF THE TUMMY TUCK. THE SURGEON OPINES THAT THIS WAS DUE TO CONTAMINATED SUTURES THAT CAUSED THE ABSCESSES. IT IS UNLIKELY THAT THE CONTAMINATION WAS DURING SURGERY BECAUSE IT IS ONLY ON ONE SIDE OF THE SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). UNSPECIFIED EVENT REQUIRING REMOVAL OF SUTURE. UNSPECIFIED EVENT REQUIRING REMOVAL OF SUTURE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07288. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A HERNIORRAPHY ON (B)(6) 2011 AND SUTURE WAS USED. THE PATIENT STATED THAT FOUR SUTURES NEEDED TO BE REMOVED BY THE PHYSICIAN IN THE OFFICE. THEN IN (B)(6) 2012, A SECOND SURGERY WAS REQUIRED TO REMOVED THE REMAINING SUTURES. DURING THE PROCEDURE, IT WAS ALSO NOTED THAT THE PATIENT HAD DEVELOPED ABSCESSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention