BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3861931 · Received May 2, 2014

    Report

    Report Number
    3004859928-2014-00043
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    December 8, 2009
    Report Date
    April 30, 2014
    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

    (B)(4). EVALUATION: DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: INCONCLUSIVE, INVESTIGATION ON-GOING. 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 FMEA AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON THE (B)(4) 2014 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(6) 2014 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT FOLLOWING IMPLANT OF POLYFORM MESH THE PATIENT SUFFERED AN INJURY. THE DATE OF IMPLANT OF THE MESH IS (B)(6) 2009. THE PATIENT IS IDENTIFIED AS "(B)(6)". THE PATIENT'S DATE OF BIRTH IS UNKNOWN; HER WEIGHT AND HEIGHT DETAILS HAVE NOT BEEN PROVIDED. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS KNOWN TO BE THE (B)(6), USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR (B)(6), CONTACT NUMBER UNKNOWN. THE IMPLANT INVOLVED IN THIS COMPLAINT IS A POLYFORM SYNTHETIC MESH - THE PART NUMBER IS A 840-240 (10X15CM); THE LOT NUMBER IS C000838. MANUFACTURING DATE 27 JULY 2009, EXPIRY DATE 31 JULY 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265663 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC - FTL FTL PROXY BIOMEDICAL LTD. 840-240 C000838

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other UNKNOWN IF ANY