BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 1192786 · Received October 8, 2008

    Report

    Report Number
    2210968-2008-00971
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT PRESENTED WITH A WOUND DEHISCENCE 9 TO 12 DAYS FOLLOWING AN UNSPECIFIED SURGICAL PROCEDURE. THE CUSTOMER COMMENTED THAT THE SUTURE PREMATURELY ABSORBED, HOWEVER, THE SUTURE STRAND WAS EXPLANTED AND THE PATIENT WAS RECLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA AEM309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention