BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1861276 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01241
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER. BATCH CCB849, MFG DATE: 03/08/2010, EXP DATE: 01/31/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNK PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE TIP AFTER SUTURING THE COLON. NO FRAGMENT REMAINED IN THE PT'S BODY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK