BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

    MDR report key: 2673585 · Received July 30, 2012

    Report

    Report Number
    2210968-2012-03336
    Event Type
    Malfunction
    Date Received
    July 30, 2012
    Date of Event
    June 7, 2012
    Report Date
    July 5, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAS
    PMA / PMN Number
    N17804
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2012-03337.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SEARCHING INVENTORY FOR OUTDATED PRODUCT ON (B)(6) 2012, THE ACCOUNT NOTED THAT THE TYVEK CO-POLYMER OVERWRAP WAS OPENING AND FALLING APART. THE PRODUCT WAS STORED IN A PYXIS AUTOMATED DISPENSING MACHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE SUTURE, NON ABSORBABLE GAS ETHICON, INC. NA BCP315

    Patients

    Seq Age Sex Outcome Treatment
    1