BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3800780 · Received May 8, 2014

    Report

    Report Number
    2210968-2014-05923
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    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: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LATERAL EPISIOTOMY ON (B)(6) 2014 AND SUTURE WAS USED TO SEW VAGINAL MUCOSA AND PERINEAL MUSCLE LAYER. DURING THE PROCEDURE, THE NEEDLE BROKE AND FELL INTO PERINEAL MUSCLE LAYER. THE BROKEN PIECE WAS LOCATED BY TOUCH AND RETRIEVED AFTER ADDITIONAL 1 CM INCISION PERFORMED ON PERINEAL MUSCLE LAYER. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278489 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GG2686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention