BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 1942544 · Received December 23, 2010

    Report

    Report Number
    2210968-2010-01752
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN EPISIOTOMY REPAIR PROCEDURE AFTER A VAGINAL DELIVERY IN (B)(6) 2010 AND SUTURE WAS USED TO SEW THE SKIN OF THE MEMBRANE WITH CONTINUOUS SEWING. TEN DAYS AFTER SURGERY, SUTURE END EXTRUSION WAS OBSERVED. THE SUTURE TRACTS WERE NOT HEALED WELL. THE OPERATING PHYSICIAN HAD TO REMOVE THE EXTRUDING SUTURES. INFRARED PHOTO-THERAPY WAS USED TO FACILITATE AND PROMOTE WOUND HEALING. THE EPISIOTOMY INCISION HAS HEALED ONE MONTH AFTER THE EPISIOTOMY REPAIR. THE PT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention