BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 2760430 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05650
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    ADDITIONAL INFORMATION: THE RASH PROGRESSED TO BE A FINE PAPULAR RASH ON THE FLANKS AND THEN WENT AWAY. THE PATIENT WAS TREATED WITH A MEDROL DOSE PACK AND THEN TOPICAL STEROIDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL SMALL BOWEL RESECTION AND SCAR REVISION ON (B)(6) 2012 AND SUTURE WAS USED. SEVEN DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED REDNESS AND ITCHING ON THE LOWER AREA OF THE INCISION. THE REDNESS INCREASED TO THE ENTIRE INCISION. THE PATIENT WAS TREATED WITH A MEDROL PACK. THE SYMPTOMS CONTINUED FOR SEVERAL DAYS AFTER COMPLETING THE MEDICATION BUT HAS SINCE STABILIZED. THE PATIENT WAS THAN STARTED ON A STEROID CREAM. 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 46 YR Other