BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3170386 · Received June 4, 2013

    Report

    Report Number
    3004859928-2013-00050
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    February 4, 2010
    Report Date
    May 30, 2013
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K051245
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSIONS: INCONCLUSIVE, INVESTIGATION ONGOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS PAIN, MESH EROSION, INFECTION, INCONTINENCE, FISTULA FORMATION AND DYSPAREUNIA ARE DOCUMENTED RISKS ASSOCIATED WITH THE POLYFORM DEVICE - REF DESIGN FMEA AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON (B)(6) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(6) 2013, REGARDING A POLYFORM PRODUCT FROM A PT'S LEGAL REP. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT (DATE OF IMPLANTATION IS (B)(6) 2010), THE PT INJURY OCCURRED. THE PT IS IDENTIFIED AS "(B)(6)." HER DATE OF BIRTH IS UNK, HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6). THE PHYSICIAN WHO TREATED THE PT IS DR (B)(6). CONTACT DETAILS ARE UNK. THE PT IS REPORTED TO HAVE HAD AN ADDITIONAL DEVICE, AN APOGEE VAGINAL VAULT PROLAPSE REPAIR SYSTEM, IMPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247463 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 10X15 OR 15X20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other APOGEE VAGINAL VAULT PROLAPSE REPAIR SYSTEM| IMPLANT DATE: