BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3569962 · Received December 30, 2013

    Report

    Report Number
    3004859928-2013-00218
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    November 26, 2007
    Report Date
    December 16, 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. CONCLUSIONS - INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS PAIN, MESH EROSION AND INCONTINENCE 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) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(4) 2013 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT, THE PATIENT SUFFERED MESH EROSION, URINARY INCONTINENCE, VAGINAL PAIN AND HAD TO UNDERGO FURTHER SURGICAL PROCEDURES. THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS INCLUDE CYSTOCELE, CUFF PROLAPSE, AND RECTOCELE. THE PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR OF PELVIC RELAXATION WITH MESH PLACEMENT AND CYSTOSCOPY ON THE (B)(6) 2007. THE PATIENT IS IDENTIFIED AS "(B)(6)". HER DATE OF BIRTH IS (B)(6); HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION AND FURTHER PROCEDURES TOOK PLACE IS (B)(6) USA. THE PHYSICIAN WHO TREATED THE PATIENT IS DR (B)(6), TELEPHONE NUMBER IS UNKNOWN. PART # 840-240, LOT # C000229, EXPIRY DATE 03/31/2008. AN ADDITIONAL DEVICE (AMS PERIGEE) WAS IMPLANTED HOWEVER, NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS DEVICE. ON THE (B)(6) 2013, BOTH THE ANTERIOR AND POSTERIOR MESHES (POLYFORM AND PERIGEE) WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680000 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 10X15CM C000229

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other AMS PERIGEE