BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 1923371 · Received November 29, 2010

    Report

    Report Number
    2210968-2010-01306
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: USER ERROR CAUSED THE EVENT. THE ATTENDING PHYSICIAN LOST BOTH VISUAL AND TACTILE CONTROL OF THE NEEDLE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A VACUUM ASSISTED INFANT DELIVERY COMPLICATED BY SHOULDER DYSTOCIA OF THE INFANT AND MORBID OBESITY OF THE MOTHER. THE PT ALSO UNDERWENT A RIGHT MEDIOLATERAL EPISIOTOMY AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE CAME AWAY FROM THE SUTURE. POST DELIVERY, IT WAS DETERMINED VIA X-RAY THAT THE NEEDLE WAS IMBEDDED IN THE BULBOCAVERNOSUS MUSCLE. THE PT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2010 WHERE THE NEEDLE WAS REMOVED UNDER LOCAL ANESTHESIA.

    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 27 YR Required Intervention