BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 2851186 · Received November 22, 2012

    Report

    Report Number
    3004859928-2012-00046
    Event Type
    Injury
    Date Received
    November 22, 2012
    Date of Event
    August 1, 2007
    Report Date
    November 22, 2012
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K051245
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CODE- DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION- INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE, INJURIES SUCH AS MESH EROSION, DYSPAREUNIA AND PAIN ARE DOCUMENTED 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 (B)(6) 2012 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2012 REGARDING A POLYFORM PRODUCT FROM A PT¿S LEGAL REP. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT, THE PT NOW SUFFERS FROM DYSPAREUNIA, EROSION, ABDOMINAL PAIN AND PELVIC PAIN. THE DATE OF IMPLANTATION OF THE MESH WAS THE (B)(6) 2007. THE PT IS IDENTIFIED AS ¿(B)(6)¿; PATIENT IS FEMALE, HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSPITAL WHERE THE IMPLANT PROCEDURE OCCURRED IS THE (B)(6) HOSPITAL, USA. THE PHYSICIAN¿S NAME IS DR (B)(6). THE POLYFORM PRODUCT PART NUMBER IS 840-240; 10CM X 15CM MESH. THE LOT NUMBER IS C000229. 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
    1 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 10X15CM C000229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other