BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFORM SYNTHETIC MESH

    MDR report key: 2848527 · Received November 9, 2012

    Report

    Report Number
    3004859928-2012-00035
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    August 14, 2012
    Report Date
    November 6, 2012
    Manufacturer
    PROXY BIOMEDICAL LTD.
    Product Code
    FTL
    PMA / PMN Number
    K051245
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 INFECTION 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 (B)(4) 2012 VIA EMAIL BY THE POLYFORM DISTRIBUTOR (BOSTON SCIENTIFIC) THAT THEY HAVE RECEIVED A COMPLAINT ON THE (B)(4), 2012, REGARDING A POLYFORM PRODUCT FROM (B)(6), AN EMPLOYEE AT THE (B)(6) HOSPITAL. THE COMPLAINT STATES THAT A PATIENT DEVELOPED A PELVIC ABSCESS APPROXIMATELY 2 DAYS FOLLOWING IMPLANTATION OF POLYFORM. THE PATIENT SUFFERED ABDOMINAL PAIN, DISTENSION, NAUSEA AND VOMITING AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT UNDERWENT EXPLORATORY SURGERY TO REMOVE THE ABSCESS. THE INFECTION WAS QUITE EXTENSIVE AND THE MESH AND SLING WERE REMOVED APPROXIMATELY 6 DAYS AFTER IMPLANT. THE PATIENT IS UNIDENTIFIED; HER DATE OF BIRTH IS UNKNOWN ALTHOUGH SHE WAS (B)(6) AT THE TIME OF THE PROCEDURE ((B)(6) 2012). HER WEIGHT AND HEIGHT ARE NOT PROVIDED. THE HOSPITAL WHERE THE IMPLANT PROCEDURE OCCURRED IS THE (B)(6) HOSPITAL. THE DATE OF IMPLANTATION OF THE MESH WAS (B)(6) 2012; THE EVENT DATE WAS THE (B)(6) 2012. POLYFORM PRODUCT LOT NUMBER WAS C001487. USER/VOLUNTARY MEDWATCH SYSTEM - REF. NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFORM SYNTHETIC MESH MESH SURGICAL, POLYMERIC FTL PROXY BIOMEDICAL LTD. 840-241 (15X20CM) C001487

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R