BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3163014 · Received May 28, 2013

    Report

    Report Number
    3004859928-2013-00045
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    December 1, 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

    EVAL CODE: DEVICE WAS NOT RETURNED FOR EVAL. CONCLUSION CODE: 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 (B)(4) AND POLYFORM PRODUCT INSERT (INSTRUCTIONS FOR USE).

    Description of Event or Problem · 1

    PROXY BIOMEDICAL WAS NOTIFIED ON (B)(4) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (B)(4) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(6) 2013, REGARDING A POLYFORM PRODUCT FROM A PT'S LEGAL REP. THE COMPLAINT STATES THAT AS A RESULT OF THE POLYFORM IMPLANT (DATE OF IMPLANTATION IS (B)(6) 2010), A PT INJURY OCCURRED. TWO OTHER DEVICES WERE IMPLANTED ON THE SAME DATE: ALIGN RS URETERAL SUPPORT SYSTEM AND AVAULTA SOLO ANTERIOR SYSTEM. THE PT IS IDENTIFIED AS "(B)(6)". HER DATE OF BIRTH IS UNK; HER WEIGHT AND HEIGHT DETAILS ARE UNK. THE HOSP WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS THE (B)(6), USA. THE PHYSICIAN WHO TREATED THE PT IS DR (B)(6), NO CONTACT INFO IS AVAILABLE FOR EITHER PHYSICIAN. THE POLYFORM PART NUMBER AND LOT NUMBER HAVE NOT BEEN PROVIDED. NO OTHER INFO REGARDING THE PRODUCT OR THE PT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232870 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 10X15CM OR 15X20CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other