BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 2892209 · Received December 21, 2012

    Report

    Report Number
    3004859928-2012-00054
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 1, 2008
    Report Date
    December 19, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION ¿ INCONCLUSIVE, INVESTIGATION ONGOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS 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 (B)(6) 2012 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(6)) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(6) 2012 REGARDING A POLYFORM PRODUCT FROM A PATIENT¿S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT ¿AS A RESULT OF THE IMPLANT, A PT INJURY OCCURRED. THE DATE OF IMPLANTATION OF THE MESH WAS (B)(6) 2008. THE PATIENT IS IDENTIFIED AS (B)(6); THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6). THE PHYSICIAN¿S NAME IS DR (B)(6). THE POLYFORM PRODUCT NUMBER AND LOT NUMBER ARE UNKNOWN. NO OTHER INFO REGARDING THE PRODUCT OR THE PATIENT 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. 10X15 OR 15X20 CM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other