BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3172714 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-06640
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 13, 2013
    Report Date
    October 4, 2024
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A VAGINAL DELIVERY ON (B)(6) 2013 AND SUTURE WAS USED TO REPAIR THE PERINEUM. DURING THE PROCEDURE THE NEEDLE BROKE OFF INTO THE PATIENT. THE SURGEON WAS UNABLE TO LOCATE THE NEEDLE FRAGMENT. THE PERINEAL TEAR WAS REPAIRED. METAL DETECTOR WAS USE TO LOCATE THE NEEDLE. THE PATIENT UNDERWENT SURGERY UNDER GENERAL ANESTHESIA. THE NEEDLE FRAGMENT WAS LOCATED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272989 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA ED5DRDN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NI.