BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1861270 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01243
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 A PT UNDERWENT AN UNK PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE THICKNESS OF THIS NEEDLE IS NOT CONSISTENT. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA BJP232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK