BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1945260 · Received December 10, 2010

    Report

    Report Number
    2210968-2010-01673
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG 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 SURGICAL PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE TIP BROKE IN PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CEK132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK