BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 2772099 · Received October 1, 2012

    Report

    Report Number
    3004859928-2012-00020
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    July 14, 2008
    Report Date
    August 17, 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

    EVALUATION: DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: INCONCLUSIVE, INVESTIGATION ON-GOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. INJURIES SUCH AS PAIN, DYSPAREUNIA, INCONTINENCE AND RECURRENCE OF PROLAPSE IS A DOCUMENTED RISK 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)(4) 2012 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(4)) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(4) 2012 REGARDING A POLYFORM PRODUCT. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT, THE PT SUFFERED SEVERE PAIN IN HER BACK, ABDOMEN AND PELVIS, DYSPAREUNIA, WORSENED INCONTINENCE AND RECURRENCE OF PROLAPSE. THE PT IS IDENTIFIED AS "LD"; SHE WAS (B)(6) AT THE TIME OF THE PROCEDURE IN 2008. HER WEIGHT AND HEIGHT ARE NOT PROVIDED. THE HOSPITAL WHERE THE IMPLANT PROCEDURE OCCURRED IS THE (B)(6) HOSPITAL, (B)(4). THE DATE OF IMPLANTATION OF THE MESH WAS (B)(6) 2008. THE PT'S PHYSICIAN WAS DR. (B)(6). INTERVENTION SURGERY WAS PERFORMED ON (B)(6) 2011 WHERE PARTIAL REMOVAL OF THE MESH TOOK PLACE. THIS SURGERY WAS PERFORMED BY DR. (B)(6). NO OTHER INFORMATION REGARDING THE PRODUCT OR THE PT IS AVAILABLE AT THIS TIME. THE POLYFORM PRODUCT LOT NUMBER HAS NOT BEEN PROVIDED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 840-240 OR 840-241 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other