BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1861282 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01240
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH CGM830 MFG DATE: 06/07/2010, EXP DATE: 01/31/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATOBILIARY SURGERY ON (B)(6) 2010 AND SUTURE WAS USED TO SEW THE FASCIA. WHEN THE SURGEON KNOTTED THE SUTURE, THE NEEDLE WAS BROKEN. THE BROKEN PART DID NOT FALL INTO THE PATIENT. 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 NEW ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK