BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 1063429 · Received June 18, 2008

    Report

    Report Number
    2210968-2008-00454
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/18/2008. CONCLUSION: A REVIEW OF THE BATCH MFG 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 ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT DEVELOPED A WOUND DEHISCENCE AT AN UNSPECIFIED TIME FOLLOWING COLON SURGERY. THE PT WAS RETURNED TO SURGERY FOR REPAIR. SURGEON REPORTS THAT NO KNOTS WERE SEEN AND SHE SAW "TWO FREE ENDS FLAPPING IN THE WIND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA ZPE323

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention