BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3246532 · Received July 18, 2013

    Report

    Report Number
    3004859928-2013-00115
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 18, 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 EVALUATION. CONCLUSION - 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 - REFERENCE DESIGN FMEA 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)(6) 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 UNKNOWN), A PATIENT INJURY OCCURRED. THE PATIENT IS IDENTIFIED AS "(B)(6)". HER DATE OF BIRTH IS UNKNOWN; HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS UNKNOWN. THE PHYSICIAN IS UNKNOWN. THE POLYFORM PART NUMBER IS 840-2401 AND LOT NUMBER IS C001588.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335525 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 10X15CM C001588

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other