BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3170385 · Received June 4, 2013

    Report

    Report Number
    3004859928-2013-00057
    Event Type
    Injury
    Date Received
    June 4, 2013
    Date of Event
    May 1, 2008
    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

    DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS PAIN, MESH EROSION, INFECTION, INCONTINENCE, FISTULA FORMATION AND DYSPAREUNIA ARE DOCUMENTED AS RISKS ASSOCIATED WITH THE POLYFORM DEVICE - REFERENCE 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 REC'D A COMPLAINT ON THE (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) 2008), A PT INJURY OCCURRED. THE PT IS IDENTIFIED AS "(B)(6)". HER DATE OF BIRTH IS UNK; HER WIGHT 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). A MONARC SUBFASCIAL HAMMOCK WAS ALSO IMPLANTED ON (B)(6) 2008. THE POLYFORM PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED. NO OTHER INFO REGARDING THE PRODUCT OR THE PT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247481 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 10X15CM OR 15X20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other REGARDING THE 2ND DEVICE HAS BEEN PROVIDED.| ANOTHER DEVICE WAS IMPLANTED IN THIS PT - NO INFO