BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3003755 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02397
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOUR UNDISPENSED SUTURES WERE RETURNED FOR EVALUATION. THE SUTURES WERE EXAMINED AND WERE INTACT AND UNDAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(4): 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.ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS:BATCH EG2221 MFG DATE: NI, EXP DATE: NI.BATCH EE2322 MFG DATE: NI, EXP DATE: NI.BATCH EG2296 MFG DATE: NI, EXP DATE: NI.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE FOR LARYNGEAL CANCER ON (B)(6) 2013 AND SUTURE WAS USED. WHILE KNOTTING THE SUTURE THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107942 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1