BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN MESH PRODUCT (EWHU)

    MDR report key: 1663802 · Received April 19, 2010

    Report

    Report Number
    2210968-2010-00392
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: PROLIFT TOTAL PELVIC FLOOR REPAIR, PROD CODE PFRT01, BATCH 3342445, MFG DATE: 09/01/2009, EXP DATE: 07/31/2012. TENSION FREE VAGINAL TAPE /OBTURATOR, PROD CODE 810081, BATCH 3288954, MFG DATE: 04/21/2009, EXP DATE: 03/31/2010. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE AND A SLING PROCEDURE ON (B) (6) 2010. FOLLOWING THE PROCEDURE, THE PATIENT FELT WEAK AFTER URINATING AND THEN LOST CONSCIOUSNESS AND EXPIRED. THE SURGEON OPINES THAT THE CAUSE OF DEATH WAS DUE TO PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MESH PRODUCT (EWHU) MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| L| R