BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 3898185 · Received June 26, 2014

    Report

    Report Number
    2210968-2014-08309
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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 UNKNOWN PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, THE PATIENT UNDERWENT AN ABLATION OF METALLIQUE CONSULTATION AND THE SUTURE BROKE FLUSH WITH THE ANCHOR AND COULD NOT BE EXTRACTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375033 SURGICAL STAINLESS STEEL SUTURE SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. UNK EA2CSRM9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other