BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 703888 · Received April 25, 2006

    Report

    Report Number
    2210968-2006-00324
    Event Type
    Injury
    Date Received
    April 25, 2006
    Date of Event
    September 29, 2003
    Report Date
    March 30, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H-6 CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. K946271.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC HAND-ASSISTED LEFT (LIVE) DONR NEPHRECTOMY IN 03. AT THE END OF THE PROCEDURE THE NURSE REPORTED AN INACCURATE NEEDLE COUNT AND AN X-RAY WAS TAKEN. A NEEDLE WAS VISUALIZED AND FELT TO BE IN THE ABDOMINAL WALL, AS IT WAS BROKEN OFF BY THE SURGEON WHEN ATTEMPTING TO CLOSE THE FASCIA. THE PT ALLEGES THAT SHE DEVELOPED HIVES FROM THE RETAINED NEEDLE TIP WHICH RESOLVED AFTER THE NEEDLE WAS REMOVED APPROX 11 MONTHS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SUTURE - PDS SUTURE| CLIPS - NOT SPECIFIED| SUTURE - DEXON