BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3163064 · Received May 28, 2013

    Report

    Report Number
    3004859928-2013-00032
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    June 3, 2010
    Report Date
    May 13, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - DEVICE WAS NOT RETURNED FOR EVALUATION. 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 (B)(4) 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) 2010), A PATIENT INJURY OCCURRED. THE PATIENT IS IDENTIFIED AS "(B)(6)." HER DATE OF BIRTH WAS THE (B)(6) 1963; HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS THE (B)(6), USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR. (B)(6). THE PATIENT HAD AN ADDITIONAL DEVICE, AN AXIS TUTOPLAST PROCESSED DERMIS, IMPLANTED ON THE (B)(6) 2010. THE POLYFORM PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED. NO OTHER INFORMATION REGARDING THE PRODUCT OR THE PATIENT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233161 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 10X15CM OR 15X20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other