BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3189814 · Received June 19, 2013

    Report

    Report Number
    3004859928-2013-00058
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    May 20, 2009
    Report Date
    June 17, 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

    THE DEVICE IS A SYNTHETIC DEVICE MADE FROM (B)(4). INJURIES SUCH AS PAIN, MESH EROSION, INFECTION, INCONTINENCE, FISTULA FORMATION AND DYSPAREUNIA ARE DOCUMENTED RISKS ASSOCIATED WITH THE POLYFORM DEVICE - REFERENCE DESIGN (B)(4) AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON THE (B)(6) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2013, REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT (DATE OF IMPLANTATION IS (B)(6) 2009), A PATIENT INJURY OCCURRED. THE PATIENT IS IDENTIFIED AS "(B)(6)." HER DATE OF BIRTH IS (B)(6); HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6), USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR. (B)(6). THE POLYFORM PART NUMBER IS 840-240, LOT NUMBER IS C000538. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279455 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 840-240 C000538

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other