BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1701386 · Received May 24, 2010

    Report

    Report Number
    2210968-2010-00546
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADD'L INFO: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THREE POSSIBLE BATCH NUMBERS ARE REPORTED AS FOLLOWS: PRODUCT CODE Z371T, BATCH BPZ940, MFG DATE: 12/01/2009, EXP DATE: 07/31/2014; PRODUCT CODE: Z371T, BATCH CCM224, MFG DATE: 03/01/2010, EXP DATE: 01/31/2015; PRODUCT CODE: Z370T, BATCH CBZ226, MFG DATE: 02/01/2010, EXP DATE: 01/31/2015. IN ADDITION, A REVIEW OF THE BATCH MFG 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 PT UNDERWENT AN UNK GYNECOLOGICAL/ OBSTETRICAL PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE TIP OF THE NEEDLE BROKE OFF AND THEY COULD NOT FIND IT. IT IS POSSIBLE THAT IT IS LEFT IN THE PATIENT. THERE ARE NO INTENTIONS OF FURTHER MEDICAL INTERVENTION. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAK ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK