BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 3894789 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08209
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE THAT WAS FRACTURED IN THE AREA ONE-THIRD OF THE DISTANCE FROM THE ATTACHMENT END WAS RECEIVED FOR EVALUATION. THE BROKEN ATTACHMENT END WHICH IS STILL ATTACHED WITH THE THREAD WAS RECEIVED, BUT THE OTHER NEEDLE PIECE IS NOT PRESENT. MICROSCOPIC EVALUATION FOUND A LOT OF INSTRUMENT MARKS AT THE ATTACHMENT AREA AND DIRECTLY AT THE BREAKING POINT, WHICH INDICATES THAT THE NEEDLE WAS HANDLED THERE. THE APPEARANCE OF THE BREAKAGE INDICATES THAT THE MATERIAL WAS OVERSTRESSED DURING USE (FIRST BENT UP AND THEN BREAKAGE).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT DID REQUIRED A REOPERATION UNDER GENERAL ANESTHESIA TO REMOVE THE NEEDLE. THE NEEDLE FRAGMENT HAS BEEN REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE LAST STITCH, IT WAS NOTED THAT THE NEEDLE WAS BROKEN. A RADIOGRAPHIC EXAMINATION CONFIRMED THE PRESENCE OF THE RETAINED NEEDLE IN THE LEFT BUTTOCK OF THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370449 VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GKX402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other