BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 834612 · Received March 9, 2007

    Report

    Report Number
    2210968-2007-00385
    Event Type
    Injury
    Date Received
    March 9, 2007
    Date of Event
    March 7, 2007
    Report Date
    March 9, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    n18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. THE ACTUAL DEVICE ASSOCIATED WITH THIS EVENT IS NOT KNOWN. INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE PRODUCTS. LOT: XK6246 MFG DATE: 09/01/2006 EXP DATE: 07/31/20011; LOT: XKM771 MFG DATE: 09/01/2006 EXP DATE: 07/31/2011; LOT: XKZ409 MFG DATE: 09/01/2006 EXP DATE: 07/31/2011; LOT: XLM908 MFG DATE: 10/01/2006 EXP DATE: 07/31/2011. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT INDENTIFY ANY NON-CONFORMANCES AND THE LOTS MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A SUTURE BROKE SEVEN DAYS FOLLOWING ABDOMINAL CLOSURE OF A RIGHT COLON RESECTION RESULTING IN A WOUND DEHISCENCE. THE PATIENT WAS RETURNED TO SURGERY FOR REPAIR. THE STATUS OF THE PATIENT IS REPORTED AS "STABLE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention