BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1810030 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00914
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION OCCURRED. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A PELVIC FLOOR PROLAPSE REPAIR PROCEDURE ON (B)(6) 2010. TWO DAYS POST-OPERATIVELY, THE PT EXPERIENCED PELVIC PAIN AND DEVELOPED A FEVER > 39.5 DEGREES CELSIUS, WHICH LED TO READMISSION ON (B)(6) 2010, FOR SUSPICION OF NOSOCOMIAL INFECTION. A GROUP A STREPTOCOCCAL (GAS) CELLULITIS ON THE TAPE WAS DIAGNOSED. THE DEVICE WAS REMOVED AND REPLACED WITH A NEW ONE. THE PT WAS TRANSFERRED TO ANOTHER HOSP AND WAS IN STABLE CONDITION IN THE INTENSIVE CARE UNIT. THE INFECTION IS NOW RESOLVED. THE PACKAGING WAS NOT DAMAGED BEFORE USE. THE DEVICE WAS PLACED WITHOUT ANY ISSUES, EXCEPT THAT THERE IS NO TRACE OF CLEANSING WITH BETADINE BEFORE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3413154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention