BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 3082769 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04637
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYELID PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE SURGERY, THE NEEDLE BROKE AND A SMALL PIECE WAS LEFT IN THE EYELID. THIS EVENT OCCURRED SEVERAL YEARS AGO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184856 UNKNOWN SUTURE PRODUCT SUTURE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other