BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1851271 · Received September 23, 2010

    Report

    Report Number
    2210968-2010-01189
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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 UNDERWENT A TENDON REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SEVERAL DAYS AFTER THE OPERATION, THE SUTURE BROKE AT THE LEADBALL LEVEL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NONABSORBABLE GAQ ETHICON, INC. NA BE2HBKM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK