BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2040273 · Received April 5, 2011

    Report

    Report Number
    2210968-2011-00382
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ETHICON SARL A JOHNSON & JOHNSON COMPANY
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERINEORRHAPHY AND A TOTAL PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2011. AT THE SIX WEEK EXAMINATION, THE PATIENT HAD DEVELOPED A BASEBALL SIZE MASS POSTERIORLY WITH PAIN WHICH ULTIMATELY DRAINED SPONTANEOUSLY. THE PATIENT WAS GIVEN CIPRO 250MG PO BID FOR 10 DAYS. THE PATIENT RETURNED ONE WEEK LATER AND SHE WAS COMPLETELY HEALED WITH NO EVIDENCE OF FLUID COLLECTIONS OR ABSCESS. A VAGINAL CULTURE RETURNED WITH YEAST BUT NO BACTERIA. THE SURGEON OPINES THAT THERE MAY HAVE BEEN A SEROMA THAT DEVELOPED UNDER THE SUTURE LINE THAT THEN DRAINED. THE SURGEON IS UNSURE IF THERE WAS A REAL ABSCESS AS THE PATIENT WAS NOT FEBRILE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON SARL A JOHNSON & JOHNSON COMPANY NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention