BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE SUTURE

    MDR report key: 1231599 · Received November 13, 2008

    Report

    Report Number
    2210968-2008-01117
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K944110
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA:11/13/2008. CONCLUSION: USER ERROR CAUSED THIS EVENT. THE MIDWIFE LOST BOTH VISUAL AND TACTILE CONTROL OF THE DEVICE DURING USE RESULTING IN THE LOST NEEDLE. THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE NEEDLE PULLED OFF THE SUTURE DURING A REPAIR OF A PERINEAL TEAR FOLLOWING VAGINAL DELIVERY. THE MIDWIFE WAS NOT ABLE TO RETRIEVE THE NEEDLE AT THE TIME OF THE EVENT. THE PT WAS RETURNED TO SURGERY THE FOLLOWING DAY FOR EXPLANT OF THE RETAINED NEEDLE. IT IS NOT KNOWN HOW THE NEEDLE BECAME DISLODGED FROM THE GRASP OF A NEEDLEHOLDER AND SUBSEQUENTLY LOST WITHIN TISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention