BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1974327 · Received January 21, 2011

    Report

    Report Number
    2210968-2011-00067
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 11, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION. RESULTS: THREE INDURATED PIECES OF TISSUE (APPROX 3X5MM, FIXED IN FORMALIN) WITH ENCLOSED BLUE THREAD MATERIAL WERE RETURNED FOR EVALUATION. EVALUATION WAS NOT POSSIBLE DUE TO THE CONDITION OF THE RETURNED SAMPLES. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: PRODUCT CODE: Z514ZH, BATCH BB5BSRN, MFG DATE: 02/13/2009, EXP DATE: 06/30/2014; PRODUCT CODE: Z4640H, BATCH AH8CMTP0, MFG DATE: 07/21/2008, EXP DATE: 12/31/2013. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER BB5BSRN WAS CONDUCTED AND THIS BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LESION EXCISION PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED ON THE DERMIS AND SUBCUTANEOUS TISSUE ON THE WRIST. ON (B)(6) 2010, THE PATIENT DEVELOPED AN INFECTION AND THE SUTURES MIGRATED AND WERE REJECTED BY THE PATIENT'S BODY. CURRENTLY, THE PATIENT IS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention