BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 3330056 · Received August 19, 2013

    Report

    Report Number
    3004859928-2013-00160
    Event Type
    Injury
    Date Received
    August 19, 2013
    Date of Event
    May 1, 2008
    Report Date
    August 19, 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

    EVALUATION: DEVICE WAS NOT RETURNED FOR EVALUATION. CONCLUSION: INCONCLUSIVE, INVESTIGATION ONGOING. THE DEVICE IS A SYNTHETIC DEVICE MADE FROM POLYPROPYLENE. 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 (B)(4) 2013 VIA EMAIL BY THE POLYFORM DISTRIBUTOR ((B)(6)) THAT THEY HAVE RECEIVED A COMPLAINT ON (B)(4) 2013 REGARDING A POLYFORM PRODUCT FROM A PATIENT'S LEGAL REPRESENTATIVE. THE COMPLAINT STATES THAT FOLLOWING IMPLANT OF POLYFORM MESH A PATIENT INJURY OCCURRED. THE DATE OF IMPLANT OF THE MESH IS (B)(6) 2008. THE PATIENT IS IDENTIFIED AS "(B)(6)." HER DATE OF BIRTH IS UNKNOWN; HER WEIGHT AND HEIGHT DETAILS ARE UNKNOWN. THE HOSPITAL WHERE THE IMPLANTATION PROCEDURE TOOK PLACE IS (B)(6). THE PATIENT ALSO HAD AN ADDITIONAL DEVICE IMPLANTED; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE FOR THIS DEVICE. THE PHYSICIAN WHO TREATED THE PATIENT IS UNKNOWN. THE IMPLANT INVOLVED IN THIS COMPLAINT IS A POLYFORM SYNTHETIC MESH - THE LOT NUMBER IS C000391 (EXPIRY DATE 30 JUNE 2009, MANUFACTURING DATE 4 JANUARY 2008).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399567 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC (FTL) FTL PROXY BIOMEDICAL LTD. 10X15CM C000391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other HOWEVER NO FURTHER INFORMATION IS AVAILABLE FOR| PATIENT ALSO HAD AN ADDITIONAL DEVICE IMPLANTED| THIS DEVICE